Global Regulatory Affairs Compliance Manager- 219589

2 weeks ago

Cranbury, United States Medix™ Full time

As the Global Regulatory Affairs Compliance Manager for the US/EU region, you will hold a pivotal position in defining and spearheading the regulatory function. Your role will involve constructing and implementing the regulatory framework for both the US and EU markets.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure successful registration and commercialization, adhering to industry standards, FDA regulations, and guidelines
  • Offer expert guidance and regulatory insight on specific controls to maintain compliance with current Good Manufacturing Practice (cGMP) standards and other relevant regulations, including procedural and documentation requirements.
  • Work closely with cross-functional teams to integrate regulatory requirements into manufacturing processes, ensuring compliance with cGMP standards and other relevant regulations.
  • Act as the company's representative in engagements with regulatory authorities, leading discussions when necessary.
  • Provide ongoing regulatory support for product sustainability, including regulatory assessments and change management.
  • Collaborate with client-facing business units to facilitate successful regulatory outcomes.
  • Proactively identify regulatory risks and suggest mitigation strategies in collaboration with relevant stakeholders.
  • Engage in regulatory surveillance activities and provide regular analysis to support existing and future processes.
  • Contribute to client meetings to support existing or prospective filings.
  • Offer regulatory surveillance to inform internal stakeholders about potential strategies, actions, and change controls for their business operations.

Education:

  • Bachelor's degree in a life sciences field is required.
  • Minimum of 5 years' experience in the pharmaceutical/biotechnology industry, including at least 6 years of relevant regulatory affairs experience in both clinical and commercial manufacturing.
  • Minimum of 10 years of relevant Regulatory Affairs experience, regionally or globally, encompassing early and late-stage development and commercial manufacturing.
  • In-depth knowledge of EU regulatory landscape with a proven track record of success in regulatory affairs.
  • Extensive experience in pharmaceuticals development, formulation, or drug product manufacturing process development.
  • Significant experience in the CMC space within the pharmaceutical industry.
  • Experience with frequent health authority inspections outside the US.
  • Proficiency in EU GMP requirements.
  • Experience with regulatory submissions.
  • Familiarity with manufacturing validation is advantageous.

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