Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist - Munich, Bayern - Life Science People

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    vor 2 Wochen

    Munich, Bayern, Deutschland ONCARE GmbH Vollzeit

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    vor 1 Monat

    Munich, Bayern, Deutschland ONCARE GmbH Vollzeit

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Regulatory Affairs Specialist

vor 2 Monaten

Munich, Bayern, Deutschland Life Science People Vollzeit

Job Overview

We are seeking a highly skilled Clinical Regulatory Consultant to support our client, a leading consultancy, in their drug development endeavors. This role will involve collaborating with cross-functional teams to ensure regulatory compliance across all stages of product development.

Key Responsibilities

  • Develop and execute regulatory strategies to support drug development and commercialization.
  • Advise on regulatory requirements for clinical trials, marketing authorization applications, and post-approval commitments.
  • Stay updated on changes in regulatory guidelines, policies, and best practices.
  • Prepare, review, and manage regulatory submissions, including IND applications, NDAs, BLAs, and MAAs.
  • Coordinate with internal and external stakeholders to compile necessary data and documents for submission to regulatory authorities.
  • Ensure timely submission of regulatory documents and responses to health authorities.
  • Ensure regulatory compliance across all stages of product development, including preclinical, clinical, and post-marketing activities.
  • Provide guidance on regulatory risk mitigation strategies and contingency planning.
  • Responsible for the global agency interaction strategy.

Qualifications

  • Bachelor's or advanced degree in life sciences, regulatory affairs, pharmacy, or a related field.
  • 10+ years of experience in regulatory affairs, with specific experience in pharmaceutical development.
  • Thorough understanding of clinical development and regulatory strategy.
  • Proven experience with regulatory submissions (IND, NDA, BLA, MAA) and clinical trial applications.
  • Strong project management skills, with the ability to work effectively across multiple projects simultaneously.
  • Excellent written and verbal communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
  • Ability to interpret complex scientific data and provide clear regulatory guidance.
  • EU and US Regulatory experience required.