Mission offers competitive salaries and a comprehensive benefit package including health insurance, generous Paid Time Off plan, company match 401(k), STD/LTD and Life insurance and more!
Internal Number: 1154
Mission is seeking an experienced and motivated individual to join our Regulatory Affairs team. The Manager - Regulatory Affairs position is responsible for the management and execution of the regulatory compliance activities of Mission and ensures that all applicable regulations and guidelines are followed (US and global).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Provides strategic and regulatory guidance relating to Manufacturing and Controls (“CMC”) in the development of strategies across all product life cycles and classifications.
Performs regulatory assessments of change controls, deviations and investigations regarding good manufacturing processes (“GMP”).
Manages multiple concurrent projects and provides project updates on set intervals.
Provides support to the International Division of Mission by assisting in overseas product registrations, declaration letters, product leaflets, renewals, modifications and other documents and filings as needed to ensure successful international regulatory compliance of all of Mission’s products.
REQUIREMENTS: Bachelor of Science degree from a four-year college or university in chemistry, pharmaceutical or related scientific field and a minimum of 8 years of industry experience in U.S. regulatory Chemistry, CMC activities, or an equivalent combination of education and experience. Intermediate skill set in Database, Presentation/PowerPoint, Microsoft Office Suite (MS Word, Excel, Outlook, etc.)
Additionally, the successful candidate must possess the following specifics:
Experience with multiple product classifications, including drug products, cosmetics, nutritional supplements, and medical devices.
Knowledge of global (US, EU, ROW, ICH, etc.) regulatory requirements and ability to demonstrate and apply such knowledge strategically and operationally across all projects.
Experienced working in a matrix environment.
Good negotiation skills and able to communicate sound regulatory advice based on regulations as well as the business needs of the organization.
Highly experienced with providing regulatory assessment of change controls, deviations and GMP investigations.
Mission Pharmacal Company ("Mission") is a privately held pharmaceutical company based in San Antonio, Texas. For more than 70 years, the company has been improving the lives of people, through every stage of life, by identifying unmet healthcare needs and delivering innovative, high-quality prescription, over-the-counter products and medical devices to meet these needs using only the purest ingredients and state-of-the-art methods of manufacturing.We are leaders in the therapeutic areas of women's health, urology, and dermatology. Mission provides a comprehensive portfolio of product and service offerings that help Mission and other pharmaceutical companies more effectively deliver needed prescription and consumer products into the hands of physicians, pharmacists and ultimately, patients.