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Manager - Regulatory Affairs

8-10 years
Not Disclosed
10 Dec. 19, 2024
Job Description
Job Type: Full Time 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

Manager - Regulatory Affairs
Company: B. BRAUN MEDICAL (INDIA)
Location: New Delhi, India
Functional Area: Regulatory Affairs
Working Model: Onsite
Requisition ID: 70

Job Description:
At B. Braun, we are committed to protecting and improving global healthcare by developing innovative and sustainable solutions. Our Regulatory Affairs team plays a crucial role in ensuring that our products meet regulatory requirements and safeguard public health. The Manager - Regulatory Affairs will lead the regulatory compliance processes for our products and services in India, ensuring alignment with all applicable legislative requirements.

Key Responsibilities:

  • Strategize & Execute Submissions: Ensure timely submission of license variations and renewals to meet strict deadlines, ensuring business continuity.
  • Compliance: Ensure compliance with all applicable regulations, including the Drugs and Cosmetics Act, Legal Metrology Act, and NPPA Act.
  • Product Registration & Approvals: Coordinate approvals, registrations, and renewals for products manufactured and sold in India.
  • Regulatory Queries: Resolve queries from regulators to secure necessary permissions and approvals.
  • Product Dossier Review: Review product dossiers for regulatory submissions to minimize follow-up queries.
  • Database Maintenance: Maintain an organized archive of all registration-related documents.
  • Regulatory Inspections: Prepare for and support regulatory inspections as required.
  • Vigilance & Complaints: Supervise the complaint management system and other vigilance-related activities and submissions.
  • Coordination with Stakeholders: Collaborate with various departments for input and information needed to complete applications to regulatory authorities.

Qualifications:

  • Education: Master’s in Microbiology or Bachelor’s/Master’s in Pharmacy.
  • Experience: Minimum 8-10 years of experience in Regulatory Affairs, with mandatory MNC experience.
  • Skills: Excellent communication, interpersonal, organizational, and time management skills. Ability to work cross-functionally and maintain a focus on detail.

What We Offer:
B. Braun provides an environment where innovation thrives, and people work together to drive positive change in healthcare. We value trust, transparency, and appreciation as part of our vision to protect and improve the health of people worldwide.