93 Pharmaceutical jobs in India

**The Position**
Will be responsible for executing medical affairs strategy in the assigned zone.
**Tasks & responsibilities**
+ Understand the current practices, medicines being used, and trends in relation to their respective therapeutic area through key customer contacts, attending scientific symposia and reviewing key therapeutic journals in order to provide relevant information to internal and external customers.
+ Effectively gathers and disseminates information in a concise and understandable format to both internal and external customers and position BI Medical as a preferred partner for key customers through credible and clear non-promotional communication Execute key medical projects (e.g. IIS studies) to ensure that BI interacts most efficiently with customers and key customer networks through optimal contact, so as to bring significant value to both the customer and BI
+ Participate in the implementation of the local medico marketing strategy.
+ Identify the EEs in the territory. Develop relationship with team and network for effective promotion of BI and BI products. Give feedback to the management regularly about KOL development.
+ Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication.
+ Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.)
+ Write, revise, and review labeling documents for pipeline/local products per relevant SOPs.
+ Assist regulatory affairs with EE access when appropriate.
**Requirements**
+ Education : Medical degree (preferable qualification in Pharmacology), or qualification in life-sciences.
+ Preferably 0-3 years experience on the same field and Pharmaceutical or Healthcare industry. Beginner level can apply as long as candidate is graduate of MD of Pharmacology. For professional without doctoral qualification, relevant field-based work experience of 10+ years with good scientific expertise is preferable.
+ Scientific expertise on diabetes therapy area is required.
+ Excellent interpersonal skill.
+ Basic IT Knowledge on MS Office applications
+ Role will cover in East India
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**Quality Assurance Analyst**
The QA Analyst is responsible for maintaining and advancing the quality and consistency of Optiv's client deliverables by owning deliverable template governance, contributing to internal process documentation, and conducting data analysis on consultant writing quality. This role exercises independent judgment and is critical in process improvement initiatives.
**How you'll make an impact**
+ Develop and maintain official Optiv deliverable templates, ensuring alignment with brand, style, and formatting standards.
+ Evaluate consultant writing for fluency, clarity, and grammatical accuracy, flagging systemic quality issues for feedback or escalation.
+ Analyze trends in consultant submission quality (e.g., error types, macro flag frequency) and provide data to support coaching efforts.
+ Maintain SOP documentation for QRM formatting processes and keep materials current and accessible.
+ Serve as subject matter expert on Optiv formatting and style guides across the Services organization.
+ Collaborate with QRM Specialists to support document standardization while maintaining brand integrity.
+ Performs other duties as assigned
+ Complies with all policies and standards
**What we're looking for**
+ 2-4 years experience in quality assurance, technical writing, or editing roles required.
+ Advanced proficiency in Microsoft Word, including templates, macros, and formatting tools. (Advanced proficiency)
+ Experience creating documentation and style guides. (Advanced proficiency)
+ Strong writing and editing skills with a deep understanding of grammar and tone. (Advanced proficiency)
+ Ability to analyze data and identify trends related to document quality and consultant behavior. (Proficient proficiency)
+ **Licenses and Certifications**
+ MSOS - Microsoft Office Specialist preferred
+ ASQ Certified Quality Improvement Associate (ASQ CQIA) preferred
+ Certified Professional Technical Communicator -STC preferred
+ Lean Six Sigma Certification-IASSC preferred.
+ Its mandatory to support in 2PM to 10PM shift.
**What you can expect from Optiv**
+ A company committed to championing Diversity, Equality, and Inclusion through our Employee Resource Groups ( .
+ Work/life balance
+ Professional training resources
+ Creative problem-solving and the ability to tackle unique, complex projects
+ Volunteer Opportunities. "Optiv Chips In" encourages employees to volunteer and engage with their teams and communities.
+ The ability and technology necessary to productively work remotely/from home (where applicable)
**EEO Statement**
Optiv is an equal opportunity employer. All qualified applicants for employment will be considered without regard to race, color, religion, sex, gender identity or expression, sexual orientation, pregnancy, age 40 and over, marital status, genetic information, national origin, status as an individual with a disability, military or veteran status, or any other basis protected by federal, state, or local law.
Optiv respects your privacy. By providing your information through this page or applying for a job at Optiv, you acknowledge that Optiv will collect, use, and process your information, which may include personal information and sensitive personal information, in connection with Optiv's selection and recruitment activities. For additional details on how Optiv uses and protects your personal information in the application process, click here to view our Applicant Privacy Notice ( . If you sign up to receive notifications of job postings, you may unsubscribe at any time.

**Key Accountabilities** :
The below responsibilities vary as per applicable as per the job role.
**General**
+ Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client's guidelines, and SOPs, and Global drug safety regulations
+ Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
+ Assist in development of project specific safety procedures, workflows and templates.
+ Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
+ Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
+ Delegate work as appropriate to Drug Safety Assistants
+ Liaising and collaborating with the relevant function at the client's end to facilitate the delivery of high-quality work
+ Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
+ Mentoring new recruits in the team, if required
+ Archiving the source documents and relevant emails as required
+ Responds to clients/customers in a timely manner
**Case processing**
+ Monitoring of incoming reports from various sources viz mailboxes, Eudravigilance, literature searches etc.
+ Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
+ Preform a check on overall medical cohesiveness and consistency of the document
+ Compares and analyses data provided by the affiliate with the data available on client application
+ Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
+ Creates the case on the safety database and performs Data entry into safety database
+ Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
+ Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
+ Ensures MedDRA coding in accordance with "MedDRA Term selection: Points to Consider"
+ Request follow-up and perform query management, as applicable Prepares medically cohesive case narratives based upon the reported information
+ Routes the case to the next workflow state as applicable in the safety database Performs quality checks/validation checks
+ Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
+ Case reconciliation- coordinating activities with Data Management personnel
+ Line listing and tabulation generation for safety reports i.e., periodic safety reports, ad hoc safety reports etc.
+ Supports compliance activities for ICSRs including late case investigation of ICSRs to various Health Authorities and Business Partners to determine the assignable cause for lateness and collection of lateness documentation including corrective actions, where applicable
+ Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable
**Drug Safety Reporting**
+ Quality control of case reports, line listings, and tabulations Develop Expedited Reporting Procedures
+ Maintain local drug safety reporting requirements
+ Perform registration with relevant authorities for electronic reporting on behalf of sponsor
+ Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
+ Submission of safety reports to investigators via SIS (Safety Information System)
+ Tracking and filing of submission cases as required Unblinding of SUSARs, as required
+ Collect and review metrics for measuring reporting compliance
+ Work with Global PV Information Office for collection and organization of global PV requirements
**Regulatory Affairs**
+ Compares the data received from client with the information present in database for the drug applications to be remediated; identifies and updates any missing information in the database
+ Creates new applications, regulatory events, product detail set, tasks, sequences and references in database based on instructions provided by client Responsible for maintaining and tracking changes in the life cycle of a medicinal product or device such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client.
+ Creation of variations in the regulatory database to track labeling, quality or administrative changes, creation of references for responses to health authority regarding PSUSA or PBRER, Referrals etc. in the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures.
+ Creation of reports for publishing in order to dispatch the dossier to affiliates or agency (EMA) and generation of marketing authorization status reports from the database for co-ordination of PV activities.
+ Validation the data content with the latest version of SmPC and performing the xEVMPD submissions via EMA Gateway for client's products and tracking the status of submissions and acknowledgement date.
**Literature Search and review**
+ Formulate and maintain the search strategy/strategies in line with parameters provided by the client to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from the literature database for ad hoc literature requests, regulatory requests and DSUR requests Send the citations retrieved to the requestor in the specified format Records are reviewed, and valid cases are entered into the client database Identification and maintenance of local journals in scope for local literature search
+ Performing Quality Check of the developed/updated search strategies and local journals.
+ Perform periodic review of database thesauri updates and implementation of necessary changes to the search strategies in a timely manner.
+ Interacting with internal or external contacts to resolve issues relatedto literature searches
**Skills:**
+ Sound knowledge of drug safety and the drug development process
+ Knowledge of and ability to interpret and apply global safety regulations
+ Experience in data analysis and evaluation of safety data
+ Good presentation skills
+ Analytical and problem-solving skills
+ Clear understanding of the regulatory submission process
+ Proficient in database/literature searches
+ Excellent interpersonal skills
+ Excellent verbal / written communication skills
+ Excellent organizational and prioritization skills
+ Ability to work collaboratively and effectively in a team environment
+ Client focused approach to work
+ Ability to evaluate data and draw conclusions independently
+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
+ Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
**Knowledge and Experience** :
+ Related experience in drug safety/ pharmacovigilance is desirable
+ Good knowledge of medical terminology
+ Excellent communication (written & spoken English + Japanese - JLPT N2 or above).
+ JLPT N2 or higher certification or equivalent
+ Experience with PMDA PV activities
+ Experience working with Japanese-speaking PV case processing teams
**Education:**
+ Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.), or relevant work experience in Pharmacovigilance.
+ A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Work Schedule**
Other
**Environmental Conditions**
Office
**Job Description**
**Responsibilities:**
The Regulatory Affairs Manager is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market, and for providing knowledgeable input to interdisciplinary the project teams and management.
+ Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia, ensuring timelines and standards are met.
+ Support the implementation of regulatory activities at the LSG Indian plant, ensuring compliance with QMS/GMP.
+ Collaborate with R&D, operations, QA, and product managers to meet regulatory and compliance requirements.
+ Conduct regulatory investigations and analyses, defining strategies and providing updates to cross-functional teams.
+ Prepare and manage technical files/dossiers for regulatory products, supporting global registration applications.
+ Lead local performance evaluations, tests, and clinical studies to support product registration in India.
+ Participate in Animal Health regulatory submissions and support the distributed team as needed.
+ Coordinate post-market surveillance, resolving technical complaints and implementing corrective actions.
+ Review advertisement materials for compliance with MD/IVD regulations in South Asia.
+ Analyze new and existing regulations, preparing impact assessments for LSG projects.
+ Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization.
+ Participate in regulatory/quality audits, exhibitions, and conferences.
+ Establish and maintain a network with consultants, policymakers, and regulatory agencies, such as Indian CDSCO.
+ Perform other tasks as assigned by the line manager.
**Minimum Requirements:**
Education and Qualifications:
+ Bachelor's degree or higher in Engineering, Sciences, or Medicine.
+ Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices, particularly with Indian CDSCO regulations.
**Essential Skills and Abilities:**
+ Comprehensive understanding of regulations, standards, and guidelines for In-Vitro Diagnostic and Medical Devices, especially in South Asia and Indian CDSCO regulations.
+ Acute awareness of regulatory changes and skilled in regulatory and strategic analysis.
+ Strong planning and organizational skills for regulatory submissions and project management.
+ Excellent communication skills, including written, verbal, and presentation abilities.
+ Strong project management skills with the ability to lead regulatory projects.
+ Strong analytical skills, proactive, and a resourceful problem solver.
+ Ability to work effectively under pressure and manage flexible working hours.
+ Comfortable with ambiguity and change, providing clear mentorship in uncertain regulatory environments.
+ Experience in leading compliance activities, including post-market surveillance and advertisement review.
+ Ability to establish and maintain a network with relevant consultants, policymakers, and regulatory agencies.
+ Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities.
Key Activities
Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.
Key Responsibilities Include:
+ Generate and execute of global and country-specific regulatory strategies
+ Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
+ Develop global dossiers for CMC content for initial submissions, variations and amendments
+ Support change management activities
+ Develop response strategy and respond to health authority questions
+ Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
+ Liaise with local regulatory teams to align on filing strategy
+ Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
+ Follow established department regulatory processes to ensure cross-product alignment
Knowledge and Skills
CMC- specific regulatory knowledge & experience
Education & Experience (Basic)
Doctorate degree
OR
Master's degree and 3 years of directly related experience
OR
Bachelor's degree and 5 years of directly related experience
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India. The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries.
The team member will be responsible for maintaining U.S. state and federal commercial product licenses and will collaborate with Global CMC, Site CMC, Device Regulatory, Operations, Quality, and Supply Chain teams on strategies and activities impacting licensed products.
**Roles & Responsibilities:**
Key responsibilities of the Regulatory Affairs Manager include:
+ Conducts periodic assessments of licenses / facilities andensures business practices comply with current regulations and statutes.
+ Evaluates new and existing regulations to maintain up-to-date compliance.
+ Communicatesrequirements to internal Amgen functional teams.
+ Obtains supplemental documentation from internal and external partners.
+ Prepares, reviews, and submits license applications and renewals.
+ Maintains all State Licensing documentation, submissions, and interactions with State Authorities.
+ Interfaceswith State Board of Pharmacy (BoP) and/or Department of Health (DoH).
+ Completes required annual notifications to U.S. FDA
+ Obtains DUNS and FEI numbers for new U.S. sites, as required
+ Processes Financial obligations relating to fee payment.
+ Identifies and implements process improvements for the state licensing process
+ Coaches and supports junior regulatory staff's career development
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The successful candidate will have the following qualifications:
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
+ Bachelor's degree and 5 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
**Preferred Qualifications:**
+ Degree in Life Science discipline
+ Regulatory CMC specific knowledge & experience
+ Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
+ Working knowledge of US state and/or federal licensing requirements
**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**