Sr. Regulatory Affairs Specialist

1 month ago

Philadelphia, United States Proclinical Staffing Full time

Sr. Regulatory Affairs Specialist - Contract - Philadelphia, PA

Proclinical is seeking a Senior Regulatory Affairs Specialist to join a dedicated team.

Primary Responsibilities:

The successful candidate will work independently on complex protocols, review and create core documents, and prepare health authority submissions. You will facilitate communications with reviewing entities and ensure all legal agreements are appropriately addressed. This position requires a focus on maintaining high-quality research documentation and supporting faculty sponsors and regulatory leadership.

Skills & Requirements:

  • Bachelor's degree in a relevant field.
  • 5-7 years of experience in research and 2+ years working in regulatory affairs.
  • CMC Manufacturing experience is essential.
  • Problem-solving and critical thinking abilities.
  • Effective communication skills (verbal and written).
  • Strong scientific knowledge and research design understanding.
  • Thorough knowledge of regulatory frameworks and GXPs.
  • Initiative and self-driven.
  • Detail-oriented with strong organizational and time management skills.
  • Ability to multi-task and be flexible.
  • Proficiency in Microsoft Office applications and team interconnectivity tools (Microsoft Teams, Zoom, WebEx, etc.).
  • Experience with web-based e-regulatory document management systems (e.g., Veeva Systems, eCTD) is a plus.

The Sr. Regulatory Affairs Specialist's responsibilities will be:

  • Review and create core documents (protocols, informed consents, investigator brochures, monitoring plans, etc.) and reports.
  • Prepare health authority submissions, including meetings, new IND/IDE applications, and maintenance of these applications.
  • Facilitate all communication with reviewing entities.
  • Ensure high quality and current documentation of research projects.
  • Review relevant safety information and identify potential impacts.
  • Facilitate audits and ensure inspection readiness.
  • Address legal agreements and ensure appropriate information is included.
  • Assist in creating new operating procedures, work instructions, and templates.
  • Monitor regulatory news and translate into operational changes.
  • Provide guidance and training to faculty sponsors and staff.
  • Assist regulatory leadership with metrics and reports.
  • Perform other duties as assigned.

If you are having difficulty in applying or if you have any questions, please contact Natalie Magola at n.magola@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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