Posted in Other 6 days ago.
Type: Full Time
The Associate Director of Regulatory Labeling & Promotional Review represents Global Regulatory Affairs in the cross-functional US Promotional Review Committee and, through effective partnership with the Global Regulatory lead and cross functional labeling team, facilitates development and revision of US labeling for late stage and/or commercial products, Company Core Data Sheets for late stage products, and Target Product Labels for earlier stage products. The Associate Director demonstrates extensive knowledge of and effectively communicates the US requirements for labeling and prescription drug promotion and serves as an expert on relevant regulatory history pertaining to labeling and promotion of assigned products.
PRIMARY RESPONSIBILITIES INCLUDE:
* Provide regulatory advice for the development and approval of compliant advertising and promotional materials and activities, disease state education, field training, and external communications.
* Oversee preparation and submit advertising and promotional materials to the Office of Prescription Drug Promotion (OPDP) as required.
* Develop working relationships with OPDP staff as necessary for management of accelerated approval products.
* Maintain a thorough understanding of OPDP requirements as well as knowledge of enforcement trends and provide analysis to review teams.
* Lead cross functional labeling teams to develop and maintain US Full Prescribing Information, Company Core Data Sheets, and Target Label Profiles and maintains inspection ready archival records.
* Assists international regulatory colleagues in development of local or regional labeling consistent with reference labeling.
* Assure that labeling documents are submission ready and compliant with applicable laws and regulations.
* Be responsive to business goals offering creative and compliant solutions while ensuring Company regulatory integrity and consistency in communications and activities.
* Work collaboratively with colleagues.
* Be a member of Global Regulatory Teams, as appropriate.
* Performs other related duties as assigned.
EDUCATION AND SKILLS REQUIREMENTS:
* Bachelor s degree in life sciences or related scientific discipline, advanced degree preferred, with at least 10 years of experience in pharmaceutical industry and prior experience in either labeling content development or promotional review experience.
* Must have a working knowledge of registration dossiers; orphan drug and/or accelerated approval experience is a plus.
* Ability to evaluate and recommend process improvement and suggest/implement best practices.
* Solid sense of accountability, sound judgement, and strong attention to detail.
* Experience working with stakeholders/partners at all levels, globally, across the organization.
* Excellent verbal and written communication skills.
* Proven ability to successfully manage projects and timelines, organize/track complex information, and prioritize accordingly.
* Proficiency with Microsoft Office Applications; Word, Excel, Outlook and regulatory systems.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.