Manager Regulatory Affairs

Job Description

List the main responsibilities this role regularly performs.

• • As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Interacts with regulatory agency to expedite approval of pending registration.
  • Serves as regulatory liaison throughout product lifecycle.
  • Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
  • Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
  • Serves as regulatory representative to marketing, research teams and regulatory agencies.
  • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

For example you may consider to add :

• Policy Tracking: Monitor new or changing laws, regulatory frameworks, and government proposals.
• Impact Analysis: Assess how regulatory shifts affect business operations, products, or company assets.
• Position Development: Draft official policy interpretations, corporate stances, and defense strategies for regulators.
• External Representation: Speak for the organization in industry associations, trade groups, and public policy forums.

Required Skills

• Legal and Political Acumen: Strong understanding of how legislative bodies and regulatory agencies operate.
• Communication: Ability to translate dense legal text into clear, persuasive briefs for executives and external agencies.
• Skill in collaborating with cross-functional teams and external stakeholders.