Mylan Technologies Inc.
Regulatory Affairs Specialist
Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit
Responsible for Mylan Technologies Inc. Regulatory Affairs labeling and Medical Products Division. Support for other Mylan Technologies Inc. Regulatory Affairs submissions as needed.
Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
1. Provide guidance regarding regulations that govern labeling and Drug Master Files (DMFs).
2. Preparation and submission of new and revised product labeling for Mylan Technologies Inc. (MTI) US drug products. This includes: creating original labeling; revising existing labeling in response to FDA comment, to changes in Reference Listed Drug approved labeling, to make minor or editorial changes, or as a result of changes in FDA regulations.
3. Coordination with ex US Mylan associates to create new or revised product labeling for foreign products manufactured by Mylan Technologies.
4. Interact with Label Control and other associated Mylan departments, as appropriate; to create labeling that meets both regulatory and technical requirements and to coordinate revisions and implementation.
5. Develop and maintain a working knowledge of the FDA’s “Orange Book” with regard to patent and exclusivity information for Reference listed Drugs that affect the labeling for generic products being developed and/or marketed by Mylan.
6. Responsible for tracking the labeling history of each drug product and maintaining RA labeling files.
7. Oversee all RA activities related to MTIs Medical Product’s Division (MPD) submitted products and related DMFs.
8. Prepare and submit new product DMF filings and amendments working with the appropriate technical tam.
9. Prepare and submit annual updates to each MTI DMF annually.
10. Provide technical information needed for foreign submissions based on MTI DMFs.
11. Review and approve labeling and MTI DMF change controls.
12. Attend technical meetings that require RA labeling or DMF input/guidance.
13. Research information pertaining to marketing applications through the navigation of submissions and regulatory documentation systems.
14. Maintain current knowledge of FDA regulations and guidance’s pertaining to labeling and DMFs by utilizing the FDA website and attendance at conferences.
15. Perform other duties as assigned.
Frequent use and application of technical standards, principles, theories, concepts and techniques.
Provide solutions to a variety of technical problems of moderate scope and complexity.
Minimum of 2 years of health science or related field experience with a health science or related field BS. However, a combination of experience and/or education will be taken into consideration.
Jan 22, 2013, 9:54:53 AM
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