API Regulatory Expert

We are seeking an experienced professional in Global Regulatory Affairs - API team to provide strategic guidance and support to the team in their operations.

The ideal candidate will possess a deep understanding of product, region-specific regulatory requirements and be able to provide timely regulatory support to the development team for new products, life cycle management activities planned at manufacturing sites.

Responsibilities will include providing guidance on drug master file starting materials and their suppliers, defining regulatory requirements for selection of starting materials, guiding teams for setting specifications for the starting materials, intermediates, Active Pharmaceutical Ingredient and providing inputs for defining the control strategy for PGIs, nitrosamines, any other regulatory expertise required based on scope of the products for line extensions to other markets such as China, Brazil, Europe, Japan, others.

Additional responsibilities will include participating in discussions related to new product development, phase gate meetings and integrated product meetings with formulation teams, ensuring smooth execution of regulatory filings globally according to established plan by collaborating with product delivery managers, project managers.

The selected candidate will also be responsible for monitoring and assessing progress of drug master file, DMF preparation, reviewing submissions to ensure adequate quality, developing submission strategies for alternate synthetic processes sites, liaising with regional points of contact for timely submissions and ensuring comprehensive and timely responses to regulatory queries from various geographies.

Qualifications for this role include post graduate in organic chemistry pharma, minimum 10-12 years experience in API regulatory affairs with fair understanding of GMP, quality systems, excellent communication and interpersonal skills, efficient leader and good collaborator, good influencing skills, strong analytical and problem-solving abilities, ability to take calculated risks.

Our ideal candidate will have thorough understanding of regulatory guidelines for United States, Europe, ICH guidelines, pharmacopeia's, product filing and approval requirements, inter-cultural understanding and awareness.

• Strong knowledge of global regulatory requirements, new product development, manufacturing, quality, intellectual property management, geographic specific regulatory requirements versus customer expectations, market play, regulatory requirements of all geographies especially generic drug user fee amendments, GDUFA, Brazil, China, Japan, Europe, Russia, Canada etc.
• Excellent communication and interpersonal skills, efficient leader and good collaborator, good influencing skills, strong analytical and problem-solving abilities, ability to take calculated risks.

As a member of our team, you will have the opportunity to work with a dynamic and experienced group of professionals, gain valuable experience in global regulatory affairs, develop your skills and knowledge in a rapidly changing industry, and contribute to the success of our organization.

You will also have access to ongoing training and development opportunities, collaborative work environment, and competitive compensation and benefits package.

We offer a comprehensive benefits package, including medical, dental, vision, and life insurance, 401(k) matching program, paid time off, and holidays.

Additionally, we provide opportunities for career growth and development, recognition and rewards for outstanding performance, and a positive and supportive work environment.

Join us and take the first step towards a rewarding and challenging career in global regulatory affairs.