Regulatory Affairs Specialist

POSITION TITLE: Regulatory Affairs Specialist

POSITION SUMMARY:

Pyramid Laboratories, Inc. is seeking an experienced, hands-on and detailed oriented CMC Regulatory Affairs with experience and knowledge in the areas of CMC and Analytical Methods. This individual will be overseeing and actively supporting all CMC Regulatory Affairs. Also act as the lead for all Regulatory agency CMC questions and interactions. This individual will work closely with company executives, cross-functional leadership, and Client’s Regulatory Affairs.

PRINCIPAL DUTIES:

  • Create and maintain CMC Regulatory Affairs for manufacturing and analytical activities at Pyramid.
  • Accountable for all correspondence and interactions with Regulatory agencies and any global Regulatory submissions (e.g. INDs, BLAs, NDA, ANDA, etc.) related to CMC and Analytical topics.
  • Support the build-out and management of Regulatory Affairs tools and processes.
  • Ensure appropriate CMC Regulatory compliance.
  • Aid in the collection and maintenance of regulatory intelligence.
  • Effective and timely identification and management of key Regulatory issues and risks related to CMC and Analytical Methods.
  • Act as a lead to our vendors and business partner on topics related to CMC and Analytical activities.
  • Provide CMC Regulatory guidance and input to project teams.

QUALIFICATIONS/REQUIREMENTS:

  • A minimum of 5 years of product development.
  • Regulatory Affairs experience in a biotech or pharmaceutical company with a strong background in CMC Regulatory Affairs (large molecule experience is highly preferred).
  • Experience in managing and participating in direct interactions with health authorities/Regulatory agencies and clients.
  • Demonstrated experience in leadership role in Regulatory Affairs.
  • Candidates must have a science background with an advanced degree. PhD and RAC preferred.
  • Effective problem-solving ability and communications and interpersonal skills are required to be successful.
  • Ability to multi-task effectively.

To apply for this position, please email your resume with cover letter to info@pyramidlabs.com .