Job Title: Manager Regulatory Affairs
Job ID: 20884
Location: Mumbai, India
Company: Boehringer Ingelheim
The Position
Coordinate PR completion for dossier acquisition, prepare quality documentation to ensure regulatory compliance, liaise with authorities for timely drug registration, and adapt internal SOPs to align with updated policies and regulations. Oversee testing and filing processes for compliance and approval in India.
Key Tasks & Responsibilities
Develop and execute a registration plan based on LTF or global strategic product goals.
Register pharmacovigilance (PV) complaints in internal systems as per SOPs.
Submit Periodic Safety Update Reports (PSURs) per local regulations.
Obtain dossiers and compile documentation as per regulatory checklists.
Follow up with regulators and consultants to expedite approvals.
Ensure product registrations, renewals, artworks, and PV complaints align with local regulations.
Comply with CDSCO (India), DGDA (Bangladesh), and Sri Lankan authority requirements.
Timely submission and closure of PV complaints.
Collaborate with internal teams including Global/Regional RA, Marketing, Technical, Manufacturing, Quality, Finance, and Purchase.
Register new drugs and indications based on business strategy.
Ensure regulatory-compliant packaging and update labeling accordingly.
Adapt SOPs and workflows to newly issued health authority policies.
Coordinate testing at approved labs such as IVRL, CDTL, or other government bodies.
File Forms 3 and 5 for NLEM and pricing on time.
Requirements
Education:
Graduate degree (preferably in Veterinary Sciences or Pharmacy).
Postgraduate degree (Master’s in Veterinary Sciences or Pharmacy) preferred.
Experience:
Minimum 7 years in Regulatory Affairs and Pharmacovigilance.
Familiarity with Drugs & Cosmetics Act & Rules and related schedules.
Experience with SUGAM online applications.
Knowledge of new drug approval, site registration processes.
Understanding of regulatory guidelines for India, Bangladesh, Sri Lanka, and Nepal.
Skills:
Strong communication in English and Hindi.
Organizational and multitasking capabilities.
Ability to work across cross-functional teams.
Work Location:
Mumbai, India
Application Process:
Click “Apply On Company Website” to register, upload your resume, and apply directly.
HR Direct Contact (for technical issues only):
Phone: +91-22-7145-6700
About Boehringer Ingelheim
A global biopharmaceutical leader in human and animal health with a focus on R&D and sustainable healthcare solutions. Serving over 130 markets with approximately 54,500 employees, Boehringer is known for its independent structure and long-term vision.
Learn more at www.boehringer-ingelheim.com
Why Join Boehringer Ingelheim?
Shape your own career path within a diverse and inclusive workplace.
Access to personal development, wellness programs, and health-focused initiatives.
Be part of a global effort to expand healthcare accessibility and transform lives.
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