AM / Manager / Sr. Manager – Regulatory Affairs (Clinical RA)
About the Job
AM / Manager / Sr. Manager – Regulatory Affairs (Clinical RA)
Markets: Regulated & Semi-Regulated (US, EU, WHO, Canada, Australia, New Zealand, South Africa)
📍 Location: West Side
🎓 Qualification: B.Pharm / M.Pharm / Ph.D. (Pharmacology preferred)
🧠 Experience: 10–12+ Years in Clinical Regulatory Affairs for Regulated Markets
Key Responsibilities:
- Prepare and review bioequivalence (BE) related sections for ANDA dossiers as per regulatory guidelines.
- Review BE protocols, bio-waiver data, and clinical strategies for all markets (including RoW).
- Confirm reference product selection for EU and other markets prior to study initiation.
- Prepare and review Modules 2.4 (Non-Clinical Summary) and 2.5 (Clinical Summary) for EU submissions.
- Review and update SmPC, PIL, and labeling for US, EU, and other markets to align with reference products.
- Coordinate with cross-functional teams for finalization and inclusion of clinical data in submissions.
- Prepare and respond to regulatory queries (USFDA, MHRA, etc.) related to clinical sections.
- Participate in discussions with QPPV and global teams for label and SmPC/PIL revisions.
Key Skills & Competencies:
- Strong understanding of Clinical RA & Global Regulatory Guidelines
- Expertise in eCTD submissions and dossier compilation
- Effective communication, coordination, and documentation skills
- Proficiency in regulatory software and MS Office tools
- Strong teamwork and cross-functional collaboration abilities
About the Company
Overview
BIG PHARMA JOBS is India’s leading recruitment platform dedicated exclusively to the Pharmaceutical industry. Since 2010, we have been connecting top talent with leading pharma companies through our specialized recruitment services.
We operate under our parent company, BIG IDEAS HR Consulting Pvt. Ltd., a trusted name in the HR industry. Headquartered in Ahmedabad, we have expanded our footprint with branch offices in Pune, Bangalore, Indore, Noida, and more.
Over the past decade, we have proudly partnered with 1,000+ pharma companies and successfully placed over 25,000 candidates across various domains and levels.
To further strengthen our commitment to the pharma ecosystem, we have recently launched our own job portal – a dedicated platform designed to serve pharmaceutical professionals and companies alike. This portal aims to be a one-stop recruitment solution, simplifying the hiring process and job search experience in the pharma sector.
At BIG PHARMA JOBS, our vision is to create India’s most trusted and comprehensive job portal for the pharmaceutical industry – empowering careers and building organizations, one placement at a time.
Skills
Key Details
- Experience:
- 10 to 12 years
- Job Domain/Function:
- Pharma Formulation, CRA
- Job Type:
- Work From Office
- Employment Type:
- Full Time
- Number of position(s):
- 1
- Educational qualifications:
- B.Pharma, M.Pharma, PHD