Director, Regulatory Affairs Advertising and Promotion

Crinetics Pharmaceuticals • Headquarters, KY

25d • $200,000 - $240,000

About The Position

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Director, Regulatory Affairs Advertising and Promotion reports to the Senior Director, Regulatory Affairs Advertising and Promotion and is responsible for reviewing and approving advertising and promotional or medical communications to ensure compliance with regulations, policies and procedures. The position will serve as a regulatory reviewer of the Medical, Legal, Regulatory (MLR) and/or Medical Review Committee (MRC) teams. The position will support Crinetics’ commercialization and future marketed products.

Requirements

• Bachelor’s or M.S./Ph.D. degree in scientific area.
• Minimum of 12 years with a Bachelor’s, or 10 years with an MS/PhD of relevant Regulatory Affairs experience in a biotech / pharmaceutical setting with a proven record of significant regulatory experience and accomplishments.
• Minimum of 8 years supervisory experience.
• Equivalent combination of relevant education and applicable job experience may be considered.
• Thorough knowledge of FDA advertising and promotion regulations and guidance as well as current industry and health authority trends and expectations.
• Experience with MLR or promotional review committees supporting product communications and managing regulatory submissions of promotional materials.
• Experience and understanding of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA regulations.
• Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved.
• Excellent written and oral communication skills.
• Strong organizational skills, including the ability to prioritize workload.
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting.
• Windows, MS Office (Outlook, Word, Excel, PowerPoint).
• Advanced MS Word and Adobe PDF knowledge required.

Nice To Haves

• Prior experience working at a small company with wide-ranging related responsibilities is desired.
• Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization.
• Electronic document management systems use (e.g., Veeva PromoMats) highly desired.
• Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc.)

Responsibilities

• Review medical education and commercial advertising and promotional materials, including disease state and training/education programs to ensure materials comply with applicable regulatory requirements, laws, and guidelines.
• Serve as a regulatory reviewer on the Medical, Legal, Regulatory (MLR) committee and/or Medical Review Committee (MRC) teams or other promotional review committees.
• Serve as back-up contact with the FDA Office of Prescription Drug Promotion (OPDP).
• Working with Regulatory Operations, assist with 2253 submissions.
• Monitor competitor space advertising and promotion materials.
• Provide strategic input on campaigns for compliant product communications that meet program and corporate objectives.
• Identify MLR/MRC process or system (such as Veeva) improvements.
• Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.
• Implement strategies to ensure programs are within the framework of published guidance documents and identify areas of risk.
• Assist with managing budgets for functional area.
• Translate business needs into strategic initiatives and drive quantifiable outcomes for the Regulatory Affairs Advertising and promotion group.
• Focus on immediate and short-term (<2 years) strategic planning horizon.
• Develop relationships with external parties (e.g., CROs, consultants) and stay current on industry trends and practices.
• Set high standards on deliverables while managing risks and timelines.
• Provide guidance/tutoring and train staff members as necessary.
• Other duties as assigned

Benefits

• In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
• We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Director