Regulatory Affairs Executive (FDA Liaisoning Specialist)
PSA Chemicals And Pharmaceuticals is a well-established pharmaceutical company specializing in finished formulations. We are committed to maintaining the highest standards of quality and regulatory compliance. We are currently seeking a dedicated and experienced Regulatory Affairs Executive to join our team at our Head Office in Vashi, Navi Mumbai.
Position: Regulatory Affairs Executive
Department: Regulatory Affairs
Number of Positions: 1
Location: Vashi, Navi Mumbai (Head Office)
Reporting To: Head – Regulatory Affairs
Industry: Pharmaceutical – Finished Formulations
Job Summary:
We are looking for a highly motivated Regulatory Affairs Executive with a strong focus on FDA liaisoning. This crucial role involves managing comprehensive regulatory activities for pharmaceutical finished formulations, from dossier preparation and submission to ensuring timely approvals and ongoing compliance with regulatory authorities. You will play a vital part in facilitating effective communication and coordination between the company and various drug regulatory bodies.
Key Responsibilities:
- Prepare, review, compile, and diligently maintain regulatory dossiers for pharmaceutical finished formulations, ensuring accuracy and completeness.
- Serve as a primary point of contact for FDA, State FDA, and other competent Drug Regulatory Authorities, overseeing the coordination of applications, licenses, registrations, and renewals.
- Effectively liaise with regulatory authorities, external consultants, agents, and internal departments to secure timely regulatory approvals and adeptly manage queries or deficiencies.
- Coordinate the preparation and submission of comprehensive responses to regulatory observations, ensuring strict adherence to specified timelines.
- Support all aspects of product registration, renewals, variations, and post-approval changes for both domestic and international markets.
- Ensure the consistency and integrity of information across all regulatory documentation, including dossiers, certificates, labels, and package inserts.
- Coordinate the efficient collection and meticulous management of essential regulatory documents such as Manufacturing Licenses, GMP certificates, Product Specifications, and Stability Data.
- Collaborate proactively with internal departments (QA, QC, Production, R&D, Supply Chain, Commercial) to gather necessary documentation and communicate evolving regulatory requirements.
- Maintain precise regulatory records, submission trackers, approval statuses, and commitment calendars.
Qualifications:
- Education: Essential: B.Pharm, M.Pharm, or Pharm.D / equivalent pharmaceutical qualification. Preferred: M.Pharm, MBA, or a PG Diploma in Regulatory Affairs.
- Experience: Minimum 3-4 years of relevant experience in Pharmaceutical Regulatory Affairs, with a strong background in finished formulation regulatory submissions and FDA liaisoning. Experience with international market registrations and export regulatory documentation is an added advantage.
Required Skills & Attributes:
- In-depth knowledge of pharmaceutical regulatory requirements and comprehensive dossier documentation (e.g., CTD/eCTD).
- Demonstrated practical experience in regulatory authority correspondence, follow-up, and deficiency management.
- Exceptional written and verbal communication, documentation, and analytical skills.
- Proficiency in MS Word, MS Excel, PowerPoint, and professional email communication.
- High level of accuracy, meticulous attention to detail, and robust follow-up capabilities.
- Ability to coordinate effectively across diverse departments and with external stakeholders.
- Professional, responsible, highly organized, and capable of working independently under stringent deadlines.
- Unwavering adherence to ethical conduct and strict confidentiality of sensitive information.
Walk-In Interview Details:
We invite all qualified candidates to attend our walk-in interviews.
- Dates: August 14th – August 23rd
- Time: 9:30 AM – 6:00 PM
- Location: Vashi, Navi Mumbai
- Contact Person: Dr. Navneet Gadge
- Contact Number: 8591920365
Join PSA Chemicals And Pharmaceuticals and contribute to ensuring the highest standards of regulatory compliance for our pharmaceutical products.
