Manager/Senior Manager Regulatory Affairs (Labeling)

Position Summary:Responsible for managing the initial creation of product labeling for all developmental products. Ensures that global prescribing information provide all essential information for the safe and effective use of the product.Major Duties and Responsibilities (including supervising others):1. Lead cross-functional teams in the development of the CDS, USPI (including early TPP) and other regional labeling for all developmental products2. Provide tactical and strategic guidance to Labeling Working Groups/Global Labeling Committee regarding language, placement, and regulatory content detail for regional prescribing information and CDSs3. Provide precedent searches and competitive comparison matrices4. Manage corporate review and approval of all CDSs, USPIs and other regional prescribing information5. Ensure consistency in prescribing information across products and therapeutic areas6. Ensure corporate quality standards for prescribing information are met7. Maintain repository of labeling documents, ensuring version control and document integrity of internal draft and Agency-submitted labels8. Represent functional expertise at all relevant department meetings9. Participate in the development and maintenance of policies, SOPs, and associated documents relating to corporate oversight of regional prescribing information10. Train process contributors on corporate labeling practices11. Provide comments regarding regional labeling guidance changes12. Liaise with senior management as needed to resolve critical labeling issues13. Ensure regional submission timelines are met as appropriate14. Provide guidance to the junior regulatory staff as need arises15. Perform functions of significant scope with minimal supervision 16. Assist in other regulatory activities as requiredRequirements/Qualifications:Education: BS/MS in a scientific discipline such as chemistry, pharmacy, biology or biochemistry etc. Advanced academic training is highly desirable.Experience: A minimum of 5 years of increasing documented success in regulatory affairs (preferably in labeling) with an additional 5 years or more in a relevant field of pharmaceuticals/biotechnology. Work experience in a biopharmaceutical arena is highly desirable.Experience working in a GMP pharmaceutical environmental. Competent knowledge of FDA regulations (current Code of Federal Regulations and FDA Guidances) and ICH guidelines preferred. Thorough understanding of and demonstrated ability to apply US/EU regulatory guidelines pertaining to product labeling, and CIOMS III/ V guidelines.Special Skills/Abilities: 1. Able to multi-task2. Act quickly in response to management objectives3. Self-motivated and proactive worker4. Possess professional ethics 5. Excellent planning and organizational skills6. Excellent oral and written communication skills 7. Proficiency in the use of Microsoft Word and other software programs8. Strong interpersonal /group skills with ability to direct, motivate and influence others 9. Capable of working collaboratively with colleagues in all functions. Team player10. Proven leadership qualities and ability to negotiate successful outcomes11. Ability to appropriately assess risks and formulate risk-management strategies12. Ability to interpret, understand and comply with domestic and international regulatory requirements13. Ability to coordinate information from various internal and external disciplines 14. Flexible in changing project priority15. Attention to detail and accuracy 16. Exercise good judgment and operate with large degree of independence regarding routine and non-routine assignments17. Adaptability to changing regulatory environmentsJob Complexity:1. Familiar with drug development process. Knowledgeable in the principles of global labeling.2. Flexibility to work on issues of diverse scope and apply knowledge gained to multiple tasks. Demonstrated ability to identify issues and initiative to recommend resolution strategy.Supervision: Receives minimal instructions on routine work and more specific instructions on new assignment. Work independently with minimal supervision.CLICK HERE TO APPLY MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Manager/Senior Manager Regulatory Affairs (Labeling) Location:  US-MD-Gaithersburg Status:  Full Time, Employee Job Category:  Sales/Retail/Business Development