Manager, Regulatory Affairs

LOCATION Research Triangle Park JOB TYPE Full Time, Employee CAREER LEVEL Manager (Manager/Supervisor of Staff) CATEGORY Biotech/R&D/Science RELEVANT WORK EXPERIENCE 5+ to 7 Years REFERENCE CODE 08-0208 Stiefel Laboratories is the world's largest privately held pharmaceutical company, committed to dermatology. For over 150 years, in over 100 countries around the world, Stiefel has been known as family-owned and geared towards innovative skin care products. Stiefel is currently headquartered in Coral Gables, Florida and completed the acquisition of Connetics, in January 2007. This strategic combination grew the company's employee base to approximately 4500. This strategic move further strengthened Stiefel's product line as being one of the most diverse within dermatology. The Stiefel's products treat a variety of dermatological ailments that include acne, psoriasis, fungal infections, and hyper-pigmentation. The company's top prescribed products are Duac and Brevoxyl acne medications, and Polytar dandruff shampoo. In addition, there are consumer products that include over-the-counter remedies as fungal infection treatment Zeasorb, Sarna Lotion for itchy and dry skin, and DermaVite dietary supplements. In June of 2007, Stiefel newly launched REVALÉSKIN™. The launch of REVALÉSKIN™ marks Stiefel's entrance into the highly competitive Cosmetic Dermatology market. This new aesthetic line also represents the company's first market entry as a true global brand. For more information, please log onto our company website at www.stiefel.com Manager, Regulatory Affairs JOB SUMMARY:The Regulatory Affairs Manager will be responsible for managing regulatory activities associated with post approval compliance activities.  The Manager will provide regulatory expertise in the assessment of change control documentation, will determine the regulatory strategy for change implementation, and will be primarily responsible, with oversight from the Associate Director, RA, for authoring change supplements for submission to FDA and other global regulatory agencies.  In addition, the Manager will help to manage all US post approval reporting requirements. The Manager will be a primary liaison with Stiefel manufacturing facilities and contractors and will be responsible for providing guidance with regard to the regulatory requirements for compliance with current good manufacturing practices (GMP) regulations in the U.S.  In addition, the manager will also participate on project teams to assist with regulatory strategies associated with new product introductions, as well as developing CMC strategies and providing updates for existing programs. ESSENTIAL DUTIES AND RESPONSIBILITIES:?  Oversee regulatory change control program, including performing and/or assessing multi-site change control documentation.?  Develop strategy to address CMC changes, and author change supplements, as necessary.?  Ensure all CMC documentation and regulatory submissions are prepared to meet global regulatory standards and provide information for US and worldwide submissions.?  Assist with managing post approval reporting requirements within the US market, including Annual Reports, NDA Field Alerts, Drug Listings, Establishment Registrations, etc.?  Work with QA, QC and Manufacturing to assure that all regulatory requirements are met, and provide regulatory input on project teams, as necessary.?  Advise Project Teams, Operations, Quality and R&D on appropriate CMC requirements for raw materials, manufacturing components, process intermediates, and finished products to assure adequate regulatory compliance and control for the life cycle of all regulated products.?  Advise on and/or create SOPs governing change control and post approval compliance activities.?  Perform other related duties as assigned. Requirements: QUALIFICATIONS:?  5+ years in Regulatory Affairs with experience in change control, post approval reporting, including supplement compilation and filing experience.  (Previous manufacturing or validation experience is preferred.)?  BS degree (advanced degree preferred) in a related technical or scientific discipline.?  Ability to communicate effectively orally and in writing.?  Ability to function independently.?  Highly organized.?  Capable of supporting numerous projects simultaneously.?  Strong interpersonal and communications skills, collaboration/teamwork, and adaptive skills required.?  Knowledge of US and ICH requirements for post approval compliance is a must; global experience preferred.?  Significant experience in relating FDA regulatory requirements to change evaluation and post approval reporting.?  Ability to travel as needed.  Applications/Resumes from Staffing & Recruiting Agencies will not be accepted.  Thank you for your consideration.Apply Now!