Job Title:
Manager Regulatory Affairs
Company:
Boehringer Ingelheim
Location:
Mumbai, Maharashtra, India
Job ID:
20884
Job Type:
Full-Time
Role Overview:
The Manager Regulatory Affairs will be responsible for coordinating and managing the drug registration process, preparing compliant documents, ensuring timely approval from regulatory authorities, and adapting SOPs to align with new policies and regulations. This position involves close collaboration with various internal teams and external regulators.
Key Responsibilities:
Registration & Documentation:
Prepare and submit registration plans for global strategic product registrations.
Register new drugs and new indications as per the business strategy.
Ensure preparation of quality documents and timely filing to ensure zero rejections.
Regulatory Compliance:
Follow up with regulators and consultants for timely product approvals.
Ensure compliance with CDSCO, DGDA (Bangladesh), and Sri Lankan authorities.
Ensure regulatory compliance of packaging, labeling, and testing.
Pharmacovigilance & Reporting:
Register PV complaints in internal system tools as per SOP.
Submit PSURs periodically as per local regulations.
Collaboration & Coordination:
Work with internal teams (Global RA, Regional RA, Marketing, Technical, Manufacturing, Quality, Finance, and Purchase) to ensure regulatory compliance.
Adapt and align SOPs and process flows with new policies and regulations.
Testing & Approval:
Ensure on-time testing of products at approved test labs in India, BNS, and other relevant laboratories.
Requirements:
Education:
Graduate degree in Veterinary Sciences or Pharmacy (Master’s in Veterinary Sciences/Pharmacy preferred).
Experience:
Minimum 7 years of experience in Regulatory Affairs and Pharmacovigilance.
Skills:
Strong understanding of Drugs & Cosmetics Act & Rules, New Drug Approvals, and Industry Guidelines in India, Bangladesh, Sri Lanka, and Nepal.
Familiarity with SUGAM online applications and regulatory filing processes.
Good communication skills in English and Hindi.
Why Boehringer Ingelheim?
Boehringer Ingelheim is dedicated to improving and extending lives with innovative therapies.
The company fosters a culture that values differences and promotes a respectful, friendly environment.
Employees have access to programs supporting health and wellbeing while working in a dynamic and inclusive environment.
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