Job Opportunity: Manager – Product & Regulatory Development

Company: Atnahs

Location: Vadodara

Experience Required: 2–5 years

Employment Type: Full Time, Permanent

About the Role:

Reporting to the Senior Director of Product Development, this role requires expertise in drug development and the pharmaceutical registration process. Strong attention to detail, proactive problem-solving, and confident communication with internal teams and external partners are essential.

The position is dynamic, with opportunities for continuous improvement, technical skill development, and engagement in a rapidly growing business environment.

Key Responsibilities:

· Review technical documents for regulatory submissions (e.g., Specifications, Test Procedures, Process Validation Protocols, Batch Manufacturing Records).

· Author technical modules for dossier compilation and submission.

· Develop and review product development or regulatory strategies aligned with project timelines.

· Assess ASMF/DMF documentation from API suppliers.

· Author scientific rationale for regulatory agency queries (RFIs).

· Contribute to pre-submission and planning packages for regulatory submissions (e.g., SA/pre-IND/NDA).

· Review Clinical/BA/BE Protocols in coordination with Subject Matter Experts.

· Formulate global product development, clinical, and regulatory strategies.

· Conduct due diligence for in-licensing and acquired products.

· Collaborate with stakeholders to prepare or review technical documents.

· Provide regular project updates to the Project Management team and Executives.

Desired Candidate Profile:

· Education: Master’s degree in Pharmacy (M.Pharm)

· Experience: Substantial technical authoring/regulatory experience in a multinational pharmaceutical company, including CTD (Module 2–5) authoring.

· Knowledge of recent regulatory and technical guidelines.

· Proficiency in authoring and reviewing technical documents, including clinical packages.

· Strong analytical and problem-solving skills.

· Excellent communication and presentation skills.

· Ability to meet tight deadlines in a fast-paced environment.

· Team player with a high level of integrity and professionalism.

Role Details:

· Position: Product Manager – Pharma

· Industry: Pharmaceutical & Life Sciences

· Department: Product Management

Job Opportunity: Manager – Product & Regulatory Development