596 Regulatory Affairs Manager jobs in India

Company Description

Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from Gastrointestinal to Neurology

Role Description

This is a full-time on-site role for a Regulatory Affairs Manager located in New Delhi. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory documentation, and managing quality systems. Additional tasks will include coordinating with internal teams to align business strategies with regulatory requirements, and staying updated with new regulations and guidelines.

Qualifications

• Skills in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
• Experience with Regulatory Submissions
• Proficiency in managing Quality Systems
• Strong organizational and time-management skills
• Excellent written and verbal communication skills
• Ability to work independently and meet deadlines
• Experience in the healthcare or pharmaceutical industry is a plus
• Bachelor's degree in a relevant field such as Regulatory Affairs, Life Sciences, or Pharmacy

Job Title: Senior Regulatory Manager – RoW Market

Department : Regulatory Affairs

Job Summary:

The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended for Rest of the World (RoW) markets , ensuring compliance with country-specific regulatory requirements. The role involves coordination with internal teams, external partners, and regulatory authorities to ensure timely product approvals and lifecycle management.

Key Responsibilities:

• Thorough knowledge of - Dossier Preparation & Review: Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for RoW markets (e.g., Africa, Southeast Asia, CIS, LATAM).
• Ensure dossiers are in line with current regulatory guidelines and client expectations.
• Regulatory Submissions & Approvals: Coordinate with agents for regulatory submission and queries.
• Track and manage timelines for submissions and approvals to ensure compliance with project milestones.
• Regulatory Intelligence & Compliance: Monitor changes in regulatory guidelines and keep relevant stakeholders informed.
• Ensure all submissions and regulatory strategies align with applicable national and international regulations.
• Lifecycle Management: Manage regulatory documentation for product variations, renewals, packaging/labelling updates, and post-approval changes.
• Audit & Documentation: Maintain and update regulatory databases and trackers.

Required Qualifications & Experience:

• Must have experience handling RoW markets.
• Strong knowledge of CTD/non-CTD formats and regulatory requirements of RoW markets.
• Experience in dealing with distributors/agents for regulatory submissions.

Key Skills:

• In-depth understanding of pharmaceutical regulatory processes.
• Strong documentation and technical writing skills.
• Ability to interpret and apply regulatory guidelines effectively.
• Excellent communication, coordination, and project management skills.
• Proficiency in MS Office and regulatory databases.

Work Schedule
Other
Environmental Conditions
Office

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.

Job Title:
Manager – Regulatory and Compliance

Location:
Indore

Department:
Regulatory Affairs

Role Overview:

Kimirica Hunter International is seeking a highly skilled
Manager – Regulatory and Compliance
to lead and oversee the compliance function for our diverse product portfolio. The ideal candidate will bring extensive expertise in regulatory requirements across India, the US, Europe, and other international markets, with a strong focus on cosmetics and pharmaceutical industries.

Key Responsibilities:

• Develop and lead regulatory and compliance strategies for all Kimirica products across multiple markets.
• Ensure strict adherence to global regulatory frameworks including CDSCO (India), US FDA, EU Cosmetics Regulation, BIS, and other relevant authorities.
• Manage product registrations, certifications, and approval processes in diverse international markets.
• Monitor and interpret evolving regulatory trends, standards, and guidelines.
• Collaborate closely with R&D, Legal, Production, and Marketing teams to ensure compliance throughout product development, launch, and post-market surveillance.
• Prepare and maintain comprehensive regulatory documentation, manage submissions, and coordinate internal and external audits.
• Serve as the primary liaison with regulatory agencies to facilitate timely approvals and certifications.
• Lead risk assessments, internal compliance audits, and oversee corrective actions to mitigate regulatory risks.
• Mentor and guide team members on regulatory best practices and compliance policies.

Required Skills & Qualifications:

• Minimum 8 years of experience in regulatory affairs within the cosmetics, pharmaceutical, or FMCG sectors.
• In-depth knowledge of global regulatory frameworks including FDA (US), EU Cosmetics Regulation, Indian regulations, and BIS.
• Proven track record of managing product registrations, compliance audits, labelling requirements, and testing protocols.
• Strong leadership capabilities with excellent communication, negotiation, and interpersonal skills.
• Proficiency in regulatory management software and MS Office Suite.
• Ability to work cross-functionally and manage multiple projects simultaneously.

Why Join Kimirica?

• Opportunity to lead regulatory strategy for innovative products impacting global markets.
• Collaborative and dynamic work environment.
• Career growth and development in a fast-growing industry.

How to Apply:

Interested candidates can share their CVs at

or apply through our careers page: Apply Here.

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.

Role Description

Revio Therapeutics is seeking a seasoned Regulatory Affairs Manager with 10–15 years of experience to oversee all regulatory activities across development and registration of our 505(b)(2)/Hybrid programs. This role requires deep understanding of US FDA regulations, guidances as well as for other regulated markets. The candidate should have a proven track record of handling submissions and agency interactions.

Key Responsibilities:

·   Lead and manage regulatory submissions (Pre-IND, IND/CTA/NDA/MAA and lifecycle management).

·   Prepare, compile, review, and submit high‑quality dossiers (eCTD modules 1–5).

·   Interact with global regulatory agencies; lead preparation of briefing packages and responses.

·   Ensure compliance with ICH, FDA, EMA, CDSCO and other relevant regulations.

·   Oversee labelling, variations, renewals, and post‑approval changes.

·   Mentor and supervise regulatory team members and external consultants.

Qualifications:

·   Bachelor's/Master's in Pharmacy, Life Sciences, or related discipline.

· –15 years of regulatory affairs experience with at least 5 years in a managerial role.

·   Strong experience in handling global submissions (US/EU/ROW).

·   Track record of successful interactions with health authorities.

·   Excellent leadership, communication, and organisational skills.

Success Metrics (12 months):

·   ≥2 regulatory submissions completed on time.

·   Positive outcomes from at least two agency meetings.

·   Established regulatory templates and processes across the organisation.

End-to-end management of regulatory submissions for finished dosage forms. Prepare & compile high-quality dossiers (Modules 1–5). Coordinate cross-functional teams, handle queries, ensure compliance, and support lifecycle mgmt of products.

Key Responsibilities:

• Dossier Preparation & Review: o Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for RoW markets (e.g., Africa, Southeast Asia, CIS, LATAM).
• Ensure dossiers are in line with current regulatory guidelines and client expectations.
• Regulatory Submissions & Approvals: o Coordinate with agents for regulatory submission and queries.
• Track and manage timelines for submissions and approvals to ensure compliance with project milestones.
• Regulatory Intelligence & Compliance: o Monitor changes in regulatory guidelines and keep relevant stakeholders informed.
• Ensure all submissions and regulatory strategies align with applicable national and international regulations.
• Lifecycle Management: o Manage regulatory documentation for product variations, renewals, packaging/labelling updates, and post-approval changes.
• Audit & Documentation: o Maintain and update regulatory databases and trackers.