Regulatory Affairs – Manager.

  • 16 Oct 2019
  • Mumbai
  • As per Industry Standards
  • 4 to 6 yrs

Job Criteria:

SECTOR: Healthcare
INDUSTRY: Pharmaceuticals, Biopharmaceuticals, Bulk Drugs
FUNCTION: Bio Tech/R&D/Scientist
QUALIFICATION: M. Pharm. (Pharmacy)
KEY SKILLS: ISO, GMP, FDA, Regulatory Affairs.
ROLE: Regulatory Affairs – Manager.

Job Summary:

  • Our client, a growing global health care company that manufactures pharmaceuticals and medical devices, is looking to hire a Regulatory Affairs – Manager / Executive.
  • This position is responsible for handling matters related to FDA, packaging and label claims, obtain product registrations in various countries, prepare dossiers, coordinate with the Quality Control at the factory and ensure all technical compliances.
  • This position is also responsible for liaising closely, build and maintain rapport with the regulatory authorities.
  • Responsible for the regulatory compliance of the company’s products and licenses. Reviewing company practices and advising on regulatory requirements.
  • This is a great opportunity to join an extremely stable and growing organization with an international presence. This position is an important role in meeting the company’s strategic plan for continued compliance.
  • Should be well versed with:
    1. Guidelines of ICH and other regulatory authorities.
    2. Preparation of documents for the licenses and dossiers.
    3. Preparation of documents for COPP, FSC, and other legal documents.
    4. Preparation of registration documents as per ACTD, CTD, and Country format.

Job Responsibilities:

  • Coordinating with concerned departments like Quality Assurance / Quality Control / Production to procure the documents for the compilation of dossiers and meet the submission timelines.
  • Preparation and compilation of dossier for the local FDA registration. Review and respond to technical queries related to product registration from FDA.
  • Preparation of complete dossiers in different modules of CTD / Eu CTD / ACTD etc. format for product registration in CIS, PIC/S, ASEAN/African/CIS/Gulf countries, etc. guidelines like quality, safety, etc. for the regulatory market of various countries.
  • Handling and responding to the queries raised by local as well as overseas Regulatory authorities.
  • Keeping abreast of international and local legislation, guidelines and customer practices.
  • Coordinate with International marketing authorization persons to manage and ensure compliance of regulations and on-time submissions.
  • Preparation, review, and evaluation of documents for submission to regulatory authorities in regulatory countries.
  • Review and preparation of the quality and analytical data as per the Pharmacopoeia, Specification, Batch manufacturing records, Stability, Finished product / Packaging material data for compilation of the dossier.
  • Filing documents for COPP/CPP as well as a review of BPR, Stability data, COA’s.
  • Should be conversant with Microsoft Word, Excel, PowerPoint, and Outlook.
  • Excellent interpersonal and communication (written & verbal) skills.

Job Specifications:

  • Experience: 5+ years exp. well versed with ISO, GMP, Regulatory affairs. (Must)
  • Salary: Not a limiting factor for Experienced and Result-Oriented candidates.
  • Location: Mumbai, Maharashtra, INDIA.

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