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Regulatory Affairs Manager Require at Bayer

Bayer
Pharmacareer

Website Bayer

About Bayer

Bayer Foundation envisions a world where health is accessible to all and hunger is eradicated. They believe that significant progress cannot be achieved without advancements in science and social innovation. Fundamental research and cutting-edge scientific developments are the cornerstones of progress, while social innovators drive concrete and lasting changes in communities.

Post: Manager – Regulatory Affairs

Job Description

Key Responsibilities:

  1. Regulatory Affairs Leadership:
    • Manage all regulatory activities for Radiology drug products in India, Nepal, and Sri Lanka.
    • Lead and govern the planning, development, and execution of regulatory strategies.
  2. Collaboration and Expertise:
    • Align regulatory work with business plans through cross-functional collaboration.
    • Provide regulatory insights to stakeholders for business plan development and issue management.
  3. Regulatory Activities Scope:
    • Handle maintenance and development activities with relevant health authorities for marketing authorization of Radiology contrast media.
  4. Resource Allocation:
    • Balance business objectives with regulatory priorities, ensuring optimal resource allocation.
  5. Independent Planning and Preparation:
    • Ensure regulatory planning and preparation for new chemical entities, new indications, and line extensions.
  6. Compliance and Standards:
    • Ensure regulatory functions comply with all relevant policies and practices throughout the product lifecycle.
    • Develop and implement standards for compliant practices and processes.
  7. Stakeholder Partnership:
    • Partner with stakeholders within PH and Radiology to achieve optimal outcomes.
    • Support APAC regulatory development and compliance activities.
  8. Leadership and Efficiency:
    • Provide leadership to achieve goals efficiently and effectively.
    • Ensure local maintenance of required licenses and regulatory practices reflect current best practices.
  9. Strategic and Operational Leadership:
    • Lead local regulatory strategic and operational matters in coordination with local functions.
  10. Communication and Decision Making:
    • Ensure transparent, timely, and efficient communication with business, supply chain, and global regulatory affairs.

Functional Excellence Responsibilities

  1. Operational Activities:
    • Lead operational activities to ensure diligent regulatory checks and timely delivery of documentation.
  2. Efficiency and Productivity:
    • Identify and implement goals for efficiency and productivity within the regulatory affairs organization.
  3. Resource Management:
    • Work with regional and global regulatory teams to manage resources and meet regulatory needs.
  4. Application File Preparation:
    • Ensure the preparation of application files for products and clinical trials is of acceptable standard and quality for authorities.
  5. Collaboration with Pharmacovigilance and Quality:
    • Work closely with PV for PSUR and AE reporting.
    • Provide regulatory input for managing product complaints and recall processes.
  6. Product Registration and Compliance:
    • Oversee product registration and maintenance for export products and local/regional tenders.
    • Ensure compendial/pharmacopeial compliance of input materials and finished products.
  7. Testing and Technical Support:
    • Handle test license applications and coordinate testing of drug formulations.
    • Provide technical support for the analysis of imported products by authorities.
  8. Distribution Partner Coordination:
    • Ensure regulatory objectives are met with distribution partners in Nepal and Sri Lanka, maintaining supply and compliance.

Candidate Profile

  1. Educational Background:
    • Master’s degree in Life Sciences or equivalent with 5-7 years of pharmaceutical industry experience in regulatory affairs.
  2. Experience and Skills:
    • Proven leadership in health authority interactions, project management, and resource allocation.
    • Excellent interpersonal, communication, analytical, and negotiation skills.
    • Fluency in English and local languages.
  3. Interpersonal Skills:
    • Ability to focus on multiple issues, prioritize activities, and work under time pressure.
    • Strong collaborative skills to support regional and global counterparts.

Location

  • India: Maharashtra, Thane

Division

  • Pharmaceuticals

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