We are assisting one of our fastest-growing healthcare clients in identifying a suitable candidate for the position of Regulatory Affairs.
Position: Regulatory Affairs Manager
Location: Pune
Experience: 10 years of experience in RA (APAC markets)
Job Summary
We are assisting one of our fastest-growing healthcare clients in identifying a suitable candidate for the position of Regulatory Affairs Manager.
We are seeking a detail-oriented Regulatory Affairs professional to support regulatory submissions and lifecycle management activities. The role involves coordinating with internal teams and external partners to ensure timely and compliant regulatory filings.
The ideal candidate should have end-to-end regulatory affairs experience, covering the full lifecycle from product development to post-approval management, with hands-on exposure to APAC markets such as Singapore and Malaysia.
Candidates from mid-size pharmaceutical companies with strong regulatory lifecycle management experience will be preferred.
Key Responsibilities
- Review and compile regulatory dossiers in line with applicable guidelines and market requirements.
- Coordinate with manufacturers to request, follow up on, and track regulatory documents.
- Perform regulatory due diligence and gap assessments for new and existing products.
- Liaise with regulatory counterparts and support interactions with health authorities.
- Handle regulatory queries/deficiency letters and coordinate the preparation and submission of responses.
- Maintain and update regulatory document repositories and submission trackers.
- Support internal and external customer interactions related to regulatory requirements and timelines.
- Ensure compliance with internal SOPs and regulatory standards.
- Assist in post-approval activities and regulatory lifecycle management.
Qualifications & Skills
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- 10 years of experience in Regulatory Affairs within the pharmaceutical or healthcare industry.
- Proven experience handling end-to-end regulatory activities from development to post-approval lifecycle management.
- Strong understanding of CTD/eCTD dossier structure.
- Experience working with APAC regulatory markets (Singapore/Malaysia preferred).
- Good communication, coordination, and documentation skills.
- Detail-oriented with strong follow-up and stakeholder management abilities.
