Regulatory Affairs Leadership Role

7 days ago

Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

Senior Manager Regulatory Affairs Job Description

The Senior Manager Regulatory Affairs will lead a team of professionals within the Regulatory Affairs Sub-Function.

  • This role involves supervising professionals in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • The Team Leader (Professionals) of the Regulatory Affairs Sub-Function interacts with regulatory agency to expedite approval of pending registration and serves as regulatory liaison throughout product lifecycle.
  • This position participates in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC), and ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
  • The Senior Manager Regulatory Affairs serves as regulatory representative to marketing, research teams and regulatory agencies.
  • Responsibilities include advising development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Qualifications and Skills

To be successful in this role, you should have:

  • A minimum of 4 years of relevant work experience.
  • Associates Degree (or higher).

Benefits of Working in This Role

You can expect to gain valuable experience working in a dynamic team environment, develop your skills in regulatory affairs, and contribute to the success of our company.

About the Company

We are a leading company in the medical devices and equipment industry. Our company is committed to providing high-quality products and services to our customers.

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