Regulatory Project Management Specialist

7 days ago

York, Pennsylvania, United States PSC Biotech Full time

We are seeking a highly motivated and experienced Regulatory Project Manager with a strong background in sterile injectables to join our team at PSC Biotech.

About the Role

The successful candidate will provide strategic guidance and facilitate seamless collaboration, serving as the central point of contact. Key responsibilities include coordinating resources, tracking progress, ensuring timely deliverables, and leading cross-functional teams to support product development, commercialization efforts, and regulatory requirements for a range of product types.

  • Lead and manage regulatory projects from initiation to completion, ensuring timelines and milestones are met. Conduct initial assessments for required product portfolio.
  • Develop and implement regulatory strategies for a range of drug products, including sterile injectable products.
  • Provide guidance and expertise to cross-functional teams during all stages of product development and regulatory requirements.
  • Proactively coordinate resource allocation, ensuring timely deliverables are achieved.
  • Effectively track all project progress, evaluating and developing timelines, schedules, risks, and objectives. Ensure alignment with internal and external stakeholders and project teams.
  • Proactively assess and communicate regulatory risks and opportunities. Identify potential risks, and implement corrective actions as needed.
  • Conduct and assist in gap analysis.
  • Develop, design, and implement pre-clinical studies and experimental protocols.
  • Prepare, review, and submit regulatory documents as needed, including INDs, NDAs, BLAs, MAAs, and amendments/supplements to global health authorities (e.g., FDA, EMA).

To be successful in this role, you will need:

  • Bachelor's or advanced degree in a related science discipline.
  • Minimum of 7+ years of experience in regulatory affairs within the pharmaceutical industry, with a focus on sterile injectables.
  • Advanced knowledge of global regulatory requirements and guidelines.
  • Proven success in designing and developing pre-clinical studies, experimental protocols, and processes, and analytical testing.
  • Strong knowledge and experience in evaluating drug product stability, compatibility, quality, and efficiency.
  • Proven experience in managing regulatory submissions and interactions with authorities.
  • Excellent project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
  • Strong analytical and problem-solving abilities.
  • Exceptional communication and interpersonal skills.
  • Able to travel.

PSC Biotech is committed to providing a compensation package that rewards your hard work and dedication. The estimated salary for this role is $120,000 - $160,000 per year, depending on experience.

We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. Additionally, we provide opportunities for professional growth and development, as well as a dynamic and collaborative work environment.

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