Director, Regulatory Compliance (Biotech-FDA)

Join this well funded, rapidly growing Biotech (pre IPO) as Director, Regulatory Compliance. You will lead regulatory compliance (GLP, GCP, GMP, DEA, DDMAC) function and direct and oversee the regulatory compliance for the organization. This will include ensuring the quality of the company’s records, products, and processes. He or she will support all efforts to obtain worldwide approvals to market our products.  The Manager or Director or Regulatory Compliance will manage compliance interactions and negotiations with regulatory agencies in support of investigational studies, product registrations, controlled substances, and promotional activities.
 
The Director,  Regulatory Compliance will:
Support the company’s commercial and development products to ensure compliance with all state, federal, and applicable international regulations
Review and approve all promotional materials for the company’s products
Direct interactions with the DEA and international equivalents
Interact with compliance personnel at partner companies and vendors
Ensure timely preparation of submissions of promotional materials to DDMAC
Provide regulatory compliance guidance and policies
Perform clinical and nonclinical site audits for regulatory compliance; write and review reports; ensure follow-up of observations
Work with Quality Assurance to perform internal, partner, and vendor audits
Work with Product Development and Quality Assurance to develop supplier qualification program
Work with Quality Assurance to host regulatory inspections
Maintain awareness and communicate changing regulatory agency requirements; provide training and intelligence to the organization
Job Requirements Bachelors or Masters or advanced degree in a scientific discipline, with a minimum of 8 years of increasingly responsible compliance experience in the pharmaceutical industry.
Deep and broad knowledge of worldwide compliance requirements; direct experience with pharmaceutical development and commercial processes world wide
Proven track record of effective collaboration with regulatory agencies (FDA and DEA).
Demonstrated leadership success in management, including developing and/or leading a compliance team.
Excellent verbal and written communication skills.
Evaluative, analytical, and interpretative skills enabling review and synthesis of reports and other documents used in support of regulatory approval of our products.
Some travel required.Company Overview


Kimco, a World Class Staffing Company, provides contract, contract-to-hire, and direct hire positions with prestigious California companies! These opportunities are available to YOU through specialized recruiters in these areas: Office/Admin, Tech, Finance, Professional Search, MediQuest, and Industrial. Our Recruiters are focused on matching YOUR skills and career goals with our many opportunities! For more information, visit us on-line at www.kimco.com, or call us toll-free at 1-800-649-JOBS.