APCER Life Sciences is hiring for a Senior Associate – Regulatory Affairs position in Noida, Uttar Pradesh. The opportunity is intended for experienced regulatory professionals with 3+ years of experience, an M.Pharm qualification, and hands-on exposure to US Regulatory Affairs.
The role specifically requires experience across pre-approval and post-approval regulatory activities, making it relevant for professionals looking to continue their careers in US regulatory submissions and lifecycle management.
APCER Life Sciences operates across regulatory affairs, pharmacovigilance, medical writing, medical information and quality assurance. Its regulatory services include submission management, dossier preparation, lifecycle management and support for US FDA interactions.
Job Overview
| Details | Information |
|---|---|
| Company | APCER Life Sciences |
| Position | Senior Associate – Regulatory Affairs |
| Location | Noida, Uttar Pradesh |
| Experience | 3+ years |
| Qualification | M.Pharm – Mandatory |
| Market | US Regulatory Affairs |
| Regulatory Exposure | Pre-approval & Post-approval |
| Employment Type | Not specified in the source |
| Salary | Not disclosed by the recruiter |
Key Responsibilities
The source job announcement specifies experience in pre-approval and post-approval activities. Based on the scope of APCER’s regulatory affairs services, relevant responsibilities may include:
- Supporting US Regulatory Affairs activities across the product lifecycle.
- Contributing to pre-approval regulatory activities and submission-related work.
- Supporting post-approval activities and regulatory lifecycle management.
- Reviewing and maintaining regulatory documentation and submission materials.
- Coordinating regulatory deliverables with internal and client-facing teams.
- Supporting compliance with applicable US regulatory requirements.
- Contributing to regulatory submissions, documentation review and related project activities.
APCER states that its regulatory services cover areas including INDs, NDAs, BLAs, ANDAs, regulatory document preparation, submission management, post-approval changes and interactions with the US FDA.
Eligibility and Qualifications
Candidates applying for this Senior Associate Regulatory Affairs job in Noida should meet the following requirements:
- M.Pharm is mandatory.
- Minimum 3 years of professional experience.
- Relevant experience in US Regulatory Affairs.
- Practical exposure to pre-approval regulatory activities.
- Experience with post-approval regulatory activities.
- Understanding of regulatory documentation and compliance processes.
- Ability to collaborate with cross-functional and global teams.
Candidates whose experience is primarily in US regulatory submissions and lifecycle activities should closely review their CV before applying.
How to Apply
Interested and eligible candidates can apply by sending their updated CV/resume directly to:
Candidates should ensure their CV clearly highlights:
- M.Pharm qualification
- 3+ years of experience
- US Regulatory Affairs experience
- Pre-approval regulatory experience
- Post-approval regulatory experience
- Relevant regulatory submissions and lifecycle-management experience