974 Regulatory Affairs jobs in India

Managing regulatory affairs of the organization its subsidiaries/associates Liaising

with regulatory bodies like State and Central FDA,DCI Well conversant with Drug

law/feed supplement regulation Co-ordination with purchase, marketing departments

Preparation of Applicant part and Restricted part DMFs (USDMF, EUDMF and ROW).

**Salary**: From ₹171,172.50 per year

**Benefits**:

- Health insurance
- Internet reimbursement
- Leave encashment
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (required)

Urgent Requirement - Executive/AM Regulatory Affairs

Experience - Min 3 to 5 years

Qualification - Minimum Graduate/Post Graduate

Industry - Pharma/Homeopathy

Sal. - 25k - 30k per month
- Responsible for implementation of Quality Management System as per regulatory requirements.
- Responsible for product approval from drug authority.
- Regulatory Documentation.
- Management of the Continual Improvement of the Systems, Product Quality Review Process for the Corrective and Preventive Action System.
- Accountable for the Data integrity and implementation of the SOP and policy.
- Evaluate & approval of master documents pertaining to various departments.
- Responsible for preparation and approval of all master documents like BMR, SOP, STP, SPEC, formats and checklist.
- Accountable for Control Sample Management and Stability Management.
- Responsible for implementation of QA systems for ensuring that compliance as per sops.
- Handling of market complaints.
- Responsible for external & internal audits.
- Responsible for cGMP related Training.
- Ensuring timely evaluation, approval, and closure of incidence, deviations, CAPA and change controls.
- Review, evaluation, and approval of Document on behalf of factory department in guidance of technical head.
- To follow cGMP practices and implementation of the information recorded.
- Responsible for review and approval of equipment qualification/ requalification/ validation protocols, a compilation of summary reports of the products.
- Follow-up with purchase, and export department for various for various materials and order.

**Salary**: ₹20,000.00 - ₹30,000.00 per month

**Benefits**:

- Cell phone reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Bhiwadi, Alwar - , Rajasthan: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 2 years (preferred)

Work Location: One location

Sunrise Remedies Job Opening for Regulatory Affairs (RA).

**Experience**: Minimum 2 Years
**Industries**: Pharmaceutical Company
**Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm
**Job Location**: Santej Ahmedabad.

**Key Responsibilities**:

- Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. Should know Dossier Preparation.
- Dossier preparation/review as per country specific guideline/CTD guideline
- Timely query response submission to Distributor/ MOH
- Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement)
- Preparation, review & release of artworks & sales order as per country approval
- Variation documents preparation and filing as per country requirements
- Should be able to review & interpret the requirement as per country specific/ tender guideline
- Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master file, BMR, APR etc.

Our client, a leading pharmaceutical company, is seeking a highly skilled Senior Regulatory Affairs Specialist to manage and execute global regulatory strategies for drug development programs. This is a fully remote position, requiring extensive knowledge of pharmaceutical regulatory requirements and a meticulous approach to documentation and submissions. You will be responsible for preparing, reviewing, and submitting regulatory dossiers (e.g., IND, NDA, MAA) to health authorities worldwide. This includes ensuring compliance with all applicable regulations, guidelines, and internal procedures. Key responsibilities involve liaising with cross-functional teams (R&D, clinical, manufacturing) to gather necessary information, providing regulatory guidance, and staying abreast of evolving regulatory landscapes. You will also contribute to the development of regulatory submission plans and timelines. The ideal candidate will hold a Bachelor's or Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology) or a related field, with a minimum of 5-7 years of experience in pharmaceutical regulatory affairs. Proven experience in preparing and submitting major regulatory filings is essential. Excellent written and verbal communication skills, strong analytical and problem-solving abilities, and a thorough understanding of ICH guidelines and regional regulatory requirements are critical. This is an excellent opportunity to contribute to bringing life-saving medicines to patients globally, with the convenience and flexibility of working remotely.

Mgr Regulatory Affairs
Date: Sep 5, 2025
Location:
Bangalore, India,
Company: Teva Pharmaceuticals
Job Id: 63860
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
+ Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company.
+ Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases.
+ Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.
.
**How you'll spend your day**
Regulatory Submissions
+ Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region.
+ Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity.
+ Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc)
Regulatory Intelligence/Expertise/Guidance/Education
+ Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities
+ Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams.
+ Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system.
+ Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements.
+ Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them.
+ Work closely with market RA in APAC region to complete all assigned activities
**Your experience and qualifications**
+ B. Pharm / M. Pharm (preferred) with 10+ years of experience
+ Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices.
+ Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc)
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran

**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.

+ Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations.
+ Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations.
+ Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates.
+ Coordination of labeling related activities with cross functional teams for timely launch of products.
+ Regulatory submission and filings, coordinating final labeling implementation and maintaining labeling artworks using various softwares.
+ Communication with third parties or private label distributors to gather needs and requirements of changes/labeling development.
+ Evaluation and coordinating with departments for REMS requirement for applications.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**What you will do**
**Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.**
**Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource.**
**Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.**
**Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.**
**Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature.**
**Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes.**
**Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products.**
**Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.**
**Determining and communicating submission and approval requirements.**
**What you need:**
**Required-**
**Bachelor's or Master's degree in Regulatory Affairs, Engineering or equivalent discipline is required.**
**3 - 5 years experience**
**Preferred-**
**Experience with post-market and change management is a distinct advantage**
**RAC Certification is preferred**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.