The Everest Group


*A division of The Everest Search Group, Inc., Los
  Angeles, CA
*The Everest Search Group Inc., Lake Tahoe, NV

Ranked Top 200 of America's Best Executive Search Firms in 2017 by Forbes

Director Regulatory Affairs Global Labeling


Location: Richmond, VA

Description
As a Director, Regulatory Affairs, Global Labeling you 1) guide and create policy related to the development and maintenance of compliant and up-to-date core labeling documents for development and marketed products throughout the product lifecycle, 2) provide strategic and operational regulatory labeling input, 3) work with cross-functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies and with industry labeling processes and standards and 4) educate and influence senior and peer staff on Global Labeling approaches and process that meet the needs of Regulatory Authorities.

Responsibilties
• Global Labeling Board (GLB)
• Chair/Lead Global Labeling Board to facilitate senior, executive cross-functional discussion on original, proposed DCDS/CCDS and changes to effective DCDS/CCDS, for review and approval.
• Ensure country label (e.g., US PI, EU SmPC) proposals which deviate from the DCDS/CCDS are brought to the attention of the GLB, together with rationale.
• Ensure deviations from labeling policy and procedures are brought to the attention of GLB and addressed.
• Contribute to overall Global Labeling and liability risk management strategy including review cross-company label/CCDS maintenance agreements.
• Provide input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices. Assess the impact of regulatory changes on currently approved and planned product labeling.
• Interacts with Global Regulatory Affairs worldwide to ensure timely implementation of global safety labeling changes in local product information, international consistency with the company’s safety position defined in the CCSI, and compliance with local labeling regulations. Guide/ support labeling related HA negotiations and participate in labeling negotiation meetings or teleconferences with HAs, as needed.
• CCDS Supporting Documents: Advises on the creation of high quality documents supporting changes to the CCDS with internal and/or external experts including the preparation of responses to labeling-related Health Authority queries.
• Assigns and advises on membership in cross functional expert labeling teams
• Represent Global Labeling as a member of Safety Management Teams.
• May assist in the development and maintenance of Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs).
• May represent Regulatory Affairs on product development teams, with responsibility for generating CCDS and guiding the generation of country specific labeling deliverables, in exceptional cases.
• May research and evaluate past labeling precedents for marketed drug products to help guide new label creation, in exceptional cases
• Initiate, Manage and Contribute to global labeling management and continuous improvement initiatives.
• Review and comment on emerging internal and external guidelines and regulations related to regulatory, safety, and legal topics.
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes. Represent Global Labeling during internal and external inspections
• Lead, Develop, Coach and Mentor newcomers and less experienced Global Labeling Team Members
• Performance Management Responsibility for Labeling Team Members with an expectation to grow the group as required in the coming year(s).

Qualifications
• BS or MS degree in a physical science with requisite experience and demonstrated capability in drug development and core label development and maintenance.
• Advanced degree in MD, Ph.D., PharmD, preferred.
• High computer literacy, with demonstrated proficiency in MS Word, Excel, PowerPoint and Outlook is essential. Experience with Documentum and Trackwise is a plus.
• Fluency in English as business language is essential, other languages advantageous.
• Efficient organization of information, document files, and electronic archives essential.
• At least 6-8 years in global labeling combined with at least 4-6 years in related areas of the Pharmaceutical Industry.
• At least 4-6 years in related areas of the Pharmaceutical Industry.
• In-depth, nuanced and differentiated understanding of the expectations of Health Authorities and their Inspectorates related to development and maintenance of core product labeling to include requirements for initial approval and subsequent changes based on emergent data.
• Understanding of the generalized expectations of Health Authorities related to changes to local product information in major markets.
• Demonstrable leadership and influencing skills with the capability to gather and present data and information to facilitate informed decision-making. Demonstrable conflict-resolution skills and ability to negotiate agreements amongst individuals with differing needs and expectations.
• Excellent management and project coordination skills, with ability to manage product labeling lifecycles and work flow for precise compliance with appropriate regulatory and industry standards.
• Excellent verbal and written communication skills
• Strong, demonstrable capabilities in the use of information technologies, and Microsoft Office Suite of Products