Regulatory Affairs Project Leader

2 months ago


York, Pennsylvania, United States PSC Biotech Full time
Regulatory Project Manager Position at PSC Biotech

PSC Biotech is a leading global provider of critical services in the life sciences sector, dedicated to maintaining the highest standards in healthcare product development, manufacturing, and distribution while complying with regulatory mandates. Our diverse workforce spans multiple continents, promoting a culture of teamwork, advancement, and innovation.

Experience and Advantages:

  • Engage in a vibrant, multicultural workplace with avenues for professional growth and mentorship.
  • Enjoy competitive salary packages, comprehensive benefits, and resources designed to enhance your career trajectory.

Key Responsibilities:

  • Oversee and direct regulatory projects concerning sterile injectables, ensuring adherence to timelines and project deliverables.
  • Formulate regulatory strategies, coordinate resources, and offer expertise to cross-departmental teams.
  • Monitor project developments, evaluate risks, and ensure compliance with regulatory standards.
  • Prepare and submit necessary regulatory documentation to health authorities.

Qualifications:

  • Bachelor's degree or higher in a relevant discipline.
  • A minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on sterile injectables.
  • In-depth understanding of global regulatory frameworks and proficient project management capabilities.
  • Exceptional communication, analytical, and problem-solving skills.

PSC Biotech is an Equal Opportunity Employer, dedicated to fostering diversity and inclusion within the workplace. Contribute to the advancement of the life sciences field with us.



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