11,906 Pharmaceutical Project jobs in India

Clinical Trials

Ahmedabad, Gujarat Confidential

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Job Description

Description

We are seeking an experienced Clinical Trials professional to manage and oversee clinical research studies in India. The ideal candidate will have a strong background in clinical trial design and execution, ensuring compliance with regulatory standards and the safety of trial participants.

Responsibilities
  • Design and implement clinical trial protocols in compliance with regulatory standards.
  • Monitor trial progress and ensure adherence to timelines and budgets.
  • Coordinate with various stakeholders, including sponsors, regulatory authorities, and clinical sites.
  • Collect, analyze, and interpret data from clinical trials.
  • Prepare and submit regulatory documents and reports.
  • Train and supervise clinical trial staff and investigators.
  • Ensure the safety and well-being of trial participants.
Skills and Qualifications
  • 6-16 years of experience in clinical trials or related field.
  • Strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
  • Proficiency in clinical trial management software and electronic data capture systems.
  • Excellent organizational and project management skills.
  • Strong analytical and problem-solving abilities.
  • Effective communication and interpersonal skills.
  • Ability to work collaboratively in a team environment.

Education
Post Graduate Diploma in Computer Applications (PGDCA), Master in Computer Application (M.C.A), Master OF Business Administration (M.B.A), Post Graduate Programme in Management for Executives (PGPX), Doctor of Pharmacy (PharmD), Doctor of Veterinary Medicine (DVM), Bachelor of Dental Surgery (B.D.S), Bachelor of Ayurvedic Medicine and Surgery (BAMS), Doctor of Dental Surgery/Medicine (DDS/DMD), Doctor of Nursing Practice (DNP), Bachelor Of Technology (B.Tech/B.E), Master of Library & Information Science (MLIS), Doctor of Public Health (DrPH), Master of Public Administration (MPA), PGDM, Doctor of Psychology (Psy. D./D. Psych.), Bachelor Of Computer Application (B.C.A), Masters in Technology (M.Tech/M.E), Doctor of Physical Therapy, PGP, Bachelors of Law (B.L/L.L.B), Master of Law (M.L/L.L.M), MBBS, Bachelor of Homeopathic Medicine and Surgery (BHMS), Bachelor of Business Administration (B.B.A), Doctor of Optometry, Doctor of Business Administration (DBA), Doctor of Medicine (M.D/M.S)
Skills Required
Clinical Research, Data Analysis, Regulatory Compliance, Project Management, Protocol Development, statistical software, patient recruitment, Risk Management, Quality Assurance, Budget Management
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Clinical Trials Manager

695001 Thiruvananthapuram, Kerala ₹90000 month WhatJobs

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full-time
Our client, a leading pharmaceutical research organization, is seeking an experienced Clinical Trials Manager to oversee critical research studies in Thiruvananthapuram. This role is essential for the successful planning, execution, and completion of clinical trials in compliance with regulatory standards. The ideal candidate will have a proven track record in managing complex clinical research projects, ensuring data integrity, patient safety, and adherence to protocols. You will lead and mentor a team of clinical research professionals, fostering a collaborative and high-performance environment. Key responsibilities include: Overseeing the planning, initiation, execution, and closure of clinical trials; Developing and managing trial budgets and timelines; Ensuring compliance with ICH-GCP guidelines, regulatory requirements, and study protocols; Selecting, training, and managing clinical research associates (CRAs) and site staff; Monitoring study progress and ensuring data quality and accuracy; Identifying and mitigating project risks and issues; Managing vendor relationships and contracts; Liaising with regulatory authorities and ethics committees; Preparing and submitting regulatory documents and study reports; Ensuring patient safety and protocol adherence at all study sites. You will be responsible for the overall success of multiple clinical trials, ensuring they are conducted efficiently and ethically. A strong understanding of pharmaceutical R&D and clinical operations is crucial. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field; Master's degree or equivalent experience is highly preferred; Minimum of 5-7 years of experience in clinical research, with at least 3 years in a managerial or supervisory role; In-depth knowledge of clinical trial phases, methodologies, and regulatory requirements; Proven experience managing clinical trials from start to finish; Excellent leadership, communication, and organizational skills; Strong financial management and budgeting capabilities; Ability to travel to study sites as needed. This is an exceptional opportunity to lead impactful clinical research initiatives within the pharmaceutical sector.
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Clinical Trials Coordinator - Research Operations and Clinical Trials Unit

Prayagraj, Uttar Pradesh ACT Health

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Clinical Trials Coordinator - Research Operations and Clinical Trials Unit (

Job Number:

 02NZW)
 

Description

Employment Type: Full Time, Permanent
Classification: Research Officer Grade 2 (PN 58238)
Salary: $ 84,901 – $91,501 (Plus 12% Super) 
Location:
Canberra Health Services
Section: Research Operations and Clinical Trials Unit
Closing Date:
7th September 2025

What can we offer you: 

• 

Competitive pay rates and excellent working conditions within a tertiary hospital. 

• 

Salary Packaging with many options that provide full fringe benefits tax concessions.

• 

Flexible working conditions. 

• 

Access to Employee Assistance Program.

Access to discounted gym membership.

Access to onsite Physiotherapists.

Onsite cafes, staff cafeteria, pharmacy and gift shop.

Up to $12K reimbursement of re ocation expenses for interstate candidates (subject to review and approval).

About the Role:

Research Operations and Clinical Trials Support Unit (ROCTSU) provides support for the conduct of clinical trials and research programs and projects across Canberra Health Services (CHS). The ROCTSU provides support for the conduct of clinical research in Canberra Health facilities including but not limited to Canberra Hospital, North Canberra Hospital, University of Canberra Hospital, and community health facilities. The ROCTSU participates in local and national clinical trials and research programs and projects and has active trials in varying stages ranging from regulatory submissions to trial close out. The number of participants in each trial varies from 1 to over 1000. The ROCTSU supports programs and projects across all sponsor types including pharmaceutical industry, collaborative group and investigator initiated clinical trials projects and programs that are funded through grants. The ROCTSU works closely with the Research Ethics and Governance Office to ensure safe and high-quality trial conduct.

The Clinical Trials Coordinator plays a central role in the planning, coordination, and delivery of clinical research projects within the Clinical Trials Support Unit at Canberra Hospital. Working across a diverse portfolio of studies, from early-phase investigations to large multi-site trials, the Coordinator ensures each project runs smoothly from start-up to close-out. This includes managing ethics and governance submissions, coordinating contractual and regulatory requirements, tracking key milestones, and ensuring all activities comply with Good Clinical Practice standards. The role also includes maintaining accurate records, managing databases, overseeing financial administration, and supporting quality assurance processes. The Coordinator works closely with the Research Ethics and Governance Office (REGO) and other stakeholders to ensure adherence to legislative, policy, and confidentiality requirements. Success in this position requires exceptional attention to detail, strong organisational skills, and the ability to work collaboratively within a multidisciplinary research environment. This is an exciting opportunity for a motivated individual to make a meaningful contribution to high-quality clinical research that directly benefits patient care.

For more information regarding the position duties click here for the Position Description.

Please note prior to commencement successful candidates will be required to:

• 

Undergo a pre-employment National Police Check.

Comply with Canberra Health Services Occupational Assessment, Screening and Vaccination policy.


To Apply: 

Please apply online by submitting a copy of your CV along with a 2-page Pitch, responding to the Selection Criteria, listed in the Position Description.

***Please note applications submitted via an agency will not be accepted for this position***

Canberra Health Services (CHS) is focussed on the delivery of high quality, effective, person centred care. It provides acute, sub-acute, primary and community‐based health services, to the Australian Capital Territory (ACT) and surrounding region. More information can be found on the CHS website. 

Our Vision : creating exceptional health care together 
Our Role : to be a health service that is trusted by our community
Our Values : Reliable, Progressive, Respectful and Kind

CHS is committed to workforce diversity and to creating an inclusive workplace. As part of this commitment, we welcome applications from all diversity groups. Aboriginal and Torres Strait Islander peoples, people with disability and people who identify as LGBTQIA+ are particularly encouraged to apply.

The new state-of-the-art Building 5 is now officially open at Canberra Hospital. This 44,000sqm, nine-storey facility, the largest healthcare infrastructure project in the Territory’s history, delivers cutting-edge acute clinical services. Building 5 seamlessly integrates with existing campus buildings, ensuring smooth public access, patient transportation, and efficient logistics. 

If you would like further information regarding this opportunity, please contact Christopher Burton at

#LI-DNI 

Job

: General/Administrative

Salary Range

: 84,901.00 - 91,501.00

Contact Name

: Christopher Burton

Contact Email

Closing Date

: 07/Sep/2025, 1:59:00 PM 

This advertiser has chosen not to accept applicants from your region.

Associate - PAI & Clinical Trials

Hyderabad, Andhra Pradesh Amgen

Posted 2 days ago

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Job Description

**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**What you will do**
Let's do this. Let's change the world. In this vital role you will report to the Amgen India R&D Finance lead. The R&D Finance Associate will assist in planning, quarter close and consolidation activities. The candidate is also expected to expand the centralization, automation and standardization practices established in R&D Finance team.
+ FP&A professional skilled in comprehensive financial data management, financial analysis and forecasting, ad hoc project financial support, and process optimization.
+ Support functional and consolidation teams in R&D finance
+ Master Data Maintenance including but not limited to managing and updating financial master data across all systems to ensure accuracy and integrity, cost center creation, modification, and deactivation, aligning them with the organizational structure, creation of Work Breakdown Structures (WBS) for precise project tracking and financial reporting.
+ Provide headcount and staffing support by maintaining relevant data and assisting in workforce planning. Support efficient data migration from the business planning tool to financial system
+ FE&O and Staff Support planning and Variance Analysis: Conduct variance analysis to identify trends and discrepancies between actuals and forecasts. Forecasting of certain trended/low risk planning accounts
+ Product Coding and Recovery Optimization: Support product coding processes and recovery methods to improve financial accuracy and efficiency.
+ Handle Ad hoc requests: Providing accurate and timely support to stakeholders.
We are all different, yet we all use our unique contributions to serve patients.
**Basic Qualifications:**
Master's degree and 0 to 2 years of accounting and/or finance (OR)
Bachelor's degree and 0 to 2 years accounting and/or finance (OR)
**Preferred Qualifications:**
Pharmaceutical / biotechnology industry experience
Knowledge and understanding of financial planning processes, quarter close activities
Strong analytical skills and exceptional attention to detail
Excellent discernment (e.g., knowledge of business drivers, finding solutions, and knowledge of accounting, finance, and other business areas)
**Good To Have Skills**
Big 4 and Fortune 500 FP&A experience
Capable of building models and financial reports
Technical finance knowledge and skills (accounting, planning, modeling, etc.)
Overall knowledge of financial systems and tools (e.g., SAP, Hyperion, Anaplan, Excel)
Business partnering skills. Ability to work effectively in ambiguous situations and team environment
**Soft Skills:**
Effective analytical and communication skills (both verbal and written)
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Collaborative, with a focus on achieving team goals
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
This advertiser has chosen not to accept applicants from your region.

Associate - Pai & Clinical Trials

Hyderabad, Andhra Pradesh Amgen

Posted 1 day ago

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Job Description

**Join Amgen’s Mission of Serving Patients**

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease
- we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**What you will do**
- FP&A professional skilled in comprehensive financial data management, financial analysis and forecasting, ad hoc project financial support, and process optimization.
- Support functional and consolidation teams in R&D finance
- Master Data Maintenance including but not limited to managing and updating financial master data across all systems to ensure accuracy and integrity, cost center creation, modification, and deactivation, aligning them with the organizational structure, creation of Work Breakdown Structures (WBS) for precise project tracking and financial reporting.
- Provide headcount and staffing support by maintaining relevant data and assisting in workforce planning. Support efficient data migration from the business planning tool to financial system
- FE&O and Staff Support planning and Variance Analysis: Conduct variance analysis to identify trends and discrepancies between actuals and forecasts. Forecasting of certain trended/low risk planning accounts
- Product Coding and Recovery Optimization: Support product coding processes and recovery methods to improve financial accuracy and efficiency.
- Handle Ad hoc requests: Providing accurate and timely support to stakeholders.

We are all different, yet we all use our unique contributions to serve patients.

**Basic Qualifications**:
Master’s degree and 0 to 2 years of accounting and/or finance (OR)

Bachelor’s degree and 0 to 2 years accounting and/or finance (OR)

**Preferred Qualifications**:
Pharmaceutical / biotechnology industry experience

Knowledge and understanding of financial planning processes, quarter close activities

Strong analytical skills and exceptional attention to detail

Excellent discernment (e.g., knowledge of business drivers, finding solutions, and knowledge of accounting, finance, and other business areas)

**Good To Have Skills**

Big 4 and Fortune 500 FP&A experience

Capable of building models and financial reports

Technical finance knowledge and skills (accounting, planning, modeling, etc.)

Overall knowledge of financial systems and tools (e.g., SAP, Hyperion, Anaplan, Excel)

Business partnering skills. Ability to work effectively in ambiguous situations and team environment

**Soft Skills**:
Effective analytical and communication skills (both verbal and written)

Ability to work effectively with global, virtual teams

High degree of initiative and self-motivation.

Ability to manage multiple priorities successfully.

Collaborative, with a focus on achieving team goals

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Objects in your future are closer than they appear. Join us.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
This advertiser has chosen not to accept applicants from your region.

Clinical Trials Disclosure Senior Associate

Hyderabad, Andhra Pradesh Amgen

Posted 2 days ago

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Job Description

**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**What you will do**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information
+ Work closely with cross-functional stakeholders to define redaction strategy, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Communicate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Support trend analysis and process improvement
**What we expect of you**
+ 4-9 years experience in preparing regulatory documents for public disclosure
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Basic Qualifications:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Ability to negotiate and influence
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.

Specialist, Clinical Trials Strategy & Submission

Bengaluru, Karnataka AbbVie

Posted today

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Job Description

Array
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

This advertiser has chosen not to accept applicants from your region.
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Clinical Trials Pathology Services Supervisor

Prayagraj, Uttar Pradesh ACT Health

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Job Description

Clinical Trials Pathology Services Supervisor (

Job Number:

 02NVH)
 

Description

Employment Type: Full Time, Permanent
Classification: Technical Officer Level 4 (PN 69694)
Salary: $100,650 - $14,448 (Plus 12% Super) 
Location:
The Canberra Hospital, Garran ACT
Section: Research Operations and Clinical Trials
Closing Date:
28 August 2025

What can we offer you: 

• 

Competitive pay rates and excellent working conditions within a tertiary hospital. 

• 

Salary Packaging with many options that provide full fringe benefits tax concessions.

• 

Flexible working conditions. 

12% Superannuation.

Access to Employee Assistance Program.

Access to discounted gym membership.

Access to onsite Physiotherapists.

Access to onsite cafes, staff cafeteria, pharmacy and gift shop.

• 

Up to $12K reimbursement of relo ation expenses for interstate candidates. (subject to review and approval)

About the Role:

The Clinical Trials Unit provides support for the conduct of clinical research at Canberra Hospital. The Unit currently has active trials in varying stages ranging from ethics submissions to trial close outs. The number of participants in each trial varies from approximately 1 to 1000 participants. These trials are either Pharmaceutical Sponsored trials, Collaborative or Investigator Led trials that are funded by grants such as the National Health & Medical Research Council.

The Clinical Trials Unit is establishing an in-house sample processing and coordination function to support the increasing volume and complexity of clinical research at Canberra Hospital. This newly created role will be responsible for coordinating all aspects of trial-related specimen handling, including processing, packaging, storage, transport, and documentation, in accordance with Good Clinical Practice (GCP) and sponsor requirements. The successful candidate will work closely with clinical trial coordinators, sponsors, couriers, and laboratory partners to ensure efficient and high-quality specimen management. With support of the management team, this position will play a key role in establishing new workflows, documentation, and relationships to support a scalable and sustainable service. Experience with specimen processing techniques (e.g., spinning, aliquoting, freezing), logistics coordination, and a strong understanding of trial protocols and regulatory requirements is essential. While the role does not initially have direct reports, it is expected to contribute to service development and future team expansion.

For more information regarding the position duties click here for the Position Description.

Please note prior to commencement successful candidates will be required to:

• 

Undergo a pre-employment National Police Check.

• 

Comply with Canberra Health Services Occupational Assessment, Screening and Vaccination policy.


To Apply: 

Please apply online by submitting a copy of your CV along with a 2-page cover letter or pitch, responding to the Selection Criteria, listed in the Position Description.

***Please note applications submitted via an agency will not be accepted for this position***

Canberra Health Services (CHS) is focussed on the delivery of high quality, effective, person centred care. It provides acute, sub-acute, primary and community‐based health services, to the Australian Capital Territory (ACT) and surrounding region. More information can be found on the CHS website. 

Our Vision : creating exceptional health care together 
Our Role : to be a health service that is trusted by our community
Our Values : Reliable, Progressive, Respectful and Kind

CHS is committed to workforce diversity and to creating an inclusive workplace. As part of this commitment, we welcome applications from all diversity groups. Aboriginal and Torres Strait Islander peoples, people with disability and people who identify as LGBTQIA+ are particularly encouraged to apply.

The new state-of-the-art Building 5 is now officially open at Canberra Hospital. This 44,000sqm, nine-storey facility, the largest healthcare infrastructure project in the Territory’s history, delivers cutting-edge acute clinical services. Building 5 seamlessly integrates with existing campus buildings, ensuring smooth public access, patient transportation, and efficient logistics.

If you would like further information regarding this opportunity, please contact Christopher Burton at .

#LI-DNI

Job

: General/Administrative

Salary Range

: 99,654.00 - 113,315.00

Closing Date

: 28/Aug/2025, 1:59:00 PM 

This advertiser has chosen not to accept applicants from your region.

Manager-Biologics Regulatory Affairs(Clinical Trials)

Mumbai, Maharashtra USV PRIVATE LIMITED

Posted 2 days ago

Job Viewed

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Job Description

About USV Private Limited:

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.

Function: Biologics

Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.

Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.


Job Responsibilities:

1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.

2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.

3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.

4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.

5. MOH Query response

6. Product Life cycle Management

7. RA support for Plant related QMS activities

This advertiser has chosen not to accept applicants from your region.

Manager-Biologics Regulatory Affairs(Clinical Trials)

Mumbai, Maharashtra USV PRIVATE LIMITED

Posted today

Job Viewed

Tap Again To Close

Job Description

About USV Private Limited:

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.

Function: Biologics

Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.

Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.

Job Responsibilities:

1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.

2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.

3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.

4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.

5. MOH Query response

6. Product Life cycle Management

7. RA support for Plant related QMS activities

This advertiser has chosen not to accept applicants from your region.
 

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