AGM - RA (USA) with A Foreign-based MNC Company

Greetings! & very warm welcome to BEST-FIT Recruitment Riders,

highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors.

professional career opportunity

Please see the following position summary:

• Client Name: Foreign-based MNC Company

• Position : Sr. Manager / Assistant General Manger

• Department :

  Regulatory Affairs

• Market : USA

• Products: Solid Oral Formulations

• Location : Ahmedabad

Job Profile:

Role Objective :

To lead and oversee the entire regulatory lifecycle of pharmaceutical products for the USA market, from development and pre-approval Submissions through post-approval compliance and lifecycle management, ensuring adherence to USFDA regulations and successful commercialization. To lead and manage the regulatory strategy, submission planning, and lifecycle management of pharmaceutical products for the United States market, ensuring end-to-end compliance with FDA regulations, ANDA processes, and post-approval obligations. The role includes managing cross-functional collaboration, regulatory risk mitigation, and ensuring timely product launches and updates. The candidate will ensure timely submission and compliance with all applicable FDA regulations and guidance.

Pre-Approval Regulatory Activities:

• Develop & execute regulatory strategies for ANDA submissions & compliance.
• Prepare & review Regulatory Dossiers (ANDA) for initial submission to the US-FDA.
• Provide regulatory guidance during product development, including formulation, analytical, and clinical stages.
• Liaise with the USFDA for pre-submission meetings, deficiency responses, and clarifications.
• Manage and respond to FDA queries, deficiencies, and Information
• Track application progress and communicate status updates to management.
• Ensure data integrity, accuracy, and alignment with FDA requirements and guidance documents.
• Coordinate with Formulation, Analytical, Clinical, Quality, and Supply Chain teams for necessary data compilation and Module 1-5 content.

Post-Approval Regulatory Management:

• Prepare, review, and submit Annual Reports and Post-Approval supplements to the USFDA.
• Track and manage post-approval commitments and risk mitigation plans as per FDA requirements.
• Ensure compliance with post-approval commitments and deficiency responses to the USFDA.
• Oversee change control reviews for manufacturing, packaging, analytical methods, and labelling updates.
• Monitor changes in FDA regulations and proactively update internal stakeholders and regulatory strategy.
• Monitor and update labelling and artwork in line with FDA guidance, safety updates, and monograph changes.

Compliance & Change Control:

• Review and approve change controls related to manufacturing, packaging, analytical methods, and labelling from a US regulatory perspective.
• Ensure post-approval commitments and deficiency responses to the USFDA are submitted within stipulated timelines.
• Monitor and maintain product labelling in compliance with updated regulations and safety requirements.

Documentation & Records:

• Maintain updated regulatory files, approval letters, submission archives, and correspondence with USFDA.
• Review and approve artwork, carton, and label proofs for compliance with USFDA labelling regulations.
• Ensure regulatory databases are updated with submission and approval statuses.

Cross-Functional Coordination:

• Work closely with FRD, ARD, Clinical, Manufacturing, QA, R&D, supply chain, and packaging teams to ensure regulatory compliance during the product lifecycle.
• Provide regulatory training and mentoring to team members.

Desired Profile:

• B.Pharm / M. Pharm with 10 to 15 years in Regulatory Affairs, with significant experience in both pre-approval and post-approval activities for the USA market.
• Exposure to working in US Markets is Mandatory.
• Experience in leading teams and interacting with the US-FDA.
• In-depth knowledge of USFDA regulatory requirements for pharma products across pre-and post-approval stages.
• Regulatory exposure in Europe / Canada / Australia would be added advantage.
• Experience in preparing Annual Reports, CBE, PAS, labelling supplements submissions.
• Successful track record of leading regulatory submissions and securing approvals from the USFDA.
• Excellent understanding of CMC documentation and pharmaceutical manufacturing processes.
• Skilled in regulatory writing, dossier compilation, and electronic submissions.
• Proven track record of successful post-approval submissions to USFDA and lifecycle management of formulations.
• Candidate should have exposure in Regulatory Submission & Filling on Educe Software.
• Proven track record of interactions with regulatory agencies.
• Strong project management skills with the ability to handle multiple submissions in parallel.
• Excellent interpersonal and communication skills for agency interactions and cross-functional coordination.
• Ability to compile, manage and interpret data.
• Strong written and verbal communication skills.
• Ability to independently manage projects and regulatory strategy.
• High attention to detail and strong organizational skills.
• Excellent leadership, communication, and project management abilities.
• High attention to detail, risk assessment capability, & solution-oriented mind-set
• Strong communication, negotiation, and analytical skills

Recruiter Details:

BEST - FIT Recruitment Riders

G-7, Amrit Complex,

Opp: Mahavir Jain Vidhyalaya & Jain Derasar,

R.V. Desai Road, Near Goyagate Circle,

Vadodara-390001, Gujarat, India

Mobile: 09722052906, 09722042906

E-Mail: career@bfrr.in

Website: www.bestfitrecruitment.co.in