Job Title: Regulatory Affairs Executive – FDA Liaisoning
Company: PSA Chemicals and Pharmaceuticals
Location: Vashi, Navi Mumbai
About the Role:
PSA Chemicals and Pharmaceuticals, a respected leader in finished pharmaceutical formulations, is seeking a seasoned Regulatory Affairs Executive for our Head Office. This pivotal role involves critical FDA liaisoning and ensuring comprehensive regulatory compliance for our diverse product portfolio across domestic and international markets. Reporting to the Head – Regulatory Affairs, you will be instrumental in managing regulatory submissions and upholding industry standards.
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for finished formulations, meeting country-specific requirements.
- Act as primary liaison with FDA, State FDA, and other Drug Regulatory Authorities for applications, licenses, registrations, and renewals.
- Coordinate prompt and accurate responses to all regulatory queries and deficiencies.
- Manage product lifecycle activities, from new registrations to post-approval changes, ensuring documentation consistency.
- Handle a wide range of regulatory documents including manufacturing licenses, GMP certificates, CPP/COPP, FSC, Certificates of Analysis, and Artwork.
- Provide regulatory support for international markets, coordinating export approvals and submissions.
- Collaborate cross-functionally with internal teams (QA, QC, Production, R&D) to ensure regulatory strategies are met.
Qualifications & Experience:
- Education: B.Pharm, M.Pharm, Pharm.D, or equivalent pharmaceutical qualification. A PG Diploma in Regulatory Affairs or an MBA is a strong advantage.
- Experience: Minimum 3-4 years of dedicated Regulatory Affairs experience in finished pharmaceutical formulations, with proven expertise in FDA liaisoning.
Required Skills & Attributes:
- In-depth knowledge of national and international pharmaceutical regulatory frameworks.
- Proficiency in regulatory dossier preparation (CTD/eCTD formats) and documentation.
- Excellent written/verbal communication and negotiation skills.
- Strong organizational, analytical, and problem-solving abilities with meticulous attention to detail.
- Competent in MS Office.
- Proactive follow-up, effective stakeholder coordination, confidentiality.
- Professional, responsible, with a strong sense of ownership. Willingness to travel.
How to Apply:
We invite qualified candidates to attend our walk-in interviews:
- Dates: 14th – 23rd August 2024
- Time: 9:30 AM – 6:00 PM
- Venue: PSA Chemicals and Pharmaceuticals Head Office, Vashi, Navi Mumbai.
- Contact Person for Queries: Dr. Navneet Gadge
- Contact Number: 8591920365
