Senior Manager Regulatory Affairs & Pharmacovigilance - Mumbai

7+ years

Not Disclosed

India Mumbai

10 Feb. 13, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Manager Regulatory Affairs & Pharmacovigilance

Job ID: 19011
Location: Mumbai, India

Position Overview

The Senior Manager of Regulatory Affairs & Pharmacovigilance will be responsible for coordinating and managing regulatory activities for the smooth and timely registration of pharmaceutical products in India and neighboring regions. This includes the preparation of high-quality documents, ensuring zero rejections, and maintaining compliance with local regulations. The role will involve collaboration with internal and external stakeholders, regulators, and ensuring adherence to policies and procedures.

Key Responsibilities

Regulatory Coordination & Dossier Management:
- Coordinate the completion of PR to obtain the dossier.
- Prepare quality documents in compliance with local regulations to ensure timely approvals.
- Follow up with regulators and consultants for quick approval processes.
Regulatory Submission & Monitoring:
- Prepare registration plans for products based on strategic needs and ensure timely filing of regulatory documents, including Form 3 and 5 for NLEM and pricing.
- Register new drugs and new indications aligned with business strategy.
- Ensure adherence to local regulations (CDSCO, DGDA, Sri Lanka, and others).
Pharmacovigilance (PV):
- Register PV complaints in the internal system as per SOP and ensure timely closure and submission to local authorities.
- Submit PSURs periodically as per local regulations.
Collaboration & Compliance:
- Work cross-functionally with global, regional, and local regulatory teams, marketing, technical, quality, finance, and manufacturing departments.
- Ensure the regulatory compliance of packaging and create/update labelling for products.
- Adapt and align SOPs and processes to evolving regulatory policies and requirements.
Testing & Regulatory Authorities:
- Ensure on-time testing of products at approved test labs in India and BNS.
- Liaise with regulatory authorities to ensure smooth drug registration processes.

Qualifications & Requirements

Education:
- Graduate degree (preferably in Veterinary Sciences or Pharmacy). A Master’s degree in these fields is preferred.
Experience:
- 7+ years of experience in Regulatory Affairs and Pharmacovigilance.
Skills & Knowledge:
- In-depth knowledge of the Drugs & Cosmetics Act and relevant guidelines for new drug approvals, site registrations, and packaging compliance.
- Familiarity with SUGAM online applications.
- Strong communication skills in both English and Hindi.
- Knowledge of regulatory guidelines in India, Bangladesh, Sri Lanka, and Nepal.

Why Apply?

This position offers an excellent opportunity to lead regulatory and pharmacovigilance functions at a global pharmaceutical company. You’ll be part of a dynamic and innovative team, ensuring timely and compliant product registrations and supporting the mission to improve healthcare across India and neighboring countries.

How to Apply

Click the “Apply On Company Website” button, create an account, upload your resume, and complete your application on the company website.

For technical issues or additional questions, contact HR Direct at:

Phone: +91-22-7145-6700
Email: HRDirect.PH@boehringer-ingelheim.com

Please note: Resumes should not be submitted via email. Apply directly on the company site.

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Senior Manager Regulatory Affairs & Pharmacovigilance - Mumbai

Job Description

Job Title: Senior Manager Regulatory Affairs & Pharmacovigilance

Position Overview

Key Responsibilities

Qualifications & Requirements

Why Apply?

How to Apply

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