Director Labeling
Director Labeling
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$ 180000 - 225000
1 Vacancy
Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and worklife resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
The Director of Regulatory Labeling will lead and facilitate the generation of new and revision of Core Labeling (Target Product Profile Company Core Data Sheet) and Local Labeling documents (e.g. US Prescribing Information) in collaboration with crossfunctional subject matter experts as well as external alliance partners. The qualified candidate will provide leadership in building and strengthening the regulatory labeling infrastructure and SOPs that support inspection readiness. They will serve as a key member of the Global Regulatory Team for development and marketed products contributing to the development of company goals and are responsible for integrating these goals into global labeling activities.The Opportunity to Make a Difference
- Develop and enhance labeling processes and procedures including those governing global Target Product Profile Company Core Data Sheets Company Core Safety Information (CCSI) and local or regional labeling to assure efficient and time creation and management of all labeling documents.
- Formulate and direct implementation of global labeling strategy in line with company goals
- Lead crossfunctional labeling teams for development review approval maintenance and of core and local labeling. Guide international regulatory colleagues for development of international local or regional labeling.
- Work with the Regulatory strategist on relevant Product Teams to enhance product development and assure that labeling objectives are identified understood and supported by the programs.
- Assure that labeling documents are submissionready 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
- Provide analysis of competitor labeling in the relevant therapeutic area
- Actively participate on project teams and regulatory subteams as appropriate
- Identify and alerts GRA leadership to the need for potential risk mitigation discussions
- Maintain current knowledge and understanding of applicable State and Federal laws regulations and policies related to labeling of pharmaceuticals and advises appropriate departments within the company of these requirements
- Participate in developing modifying and executing company policies that affect immediate operations and may also have companywide effect. Provides input to enhance policies standard operating procedures best practices and work instructions.
- Contribute to expansion of the regulatory labeling staff as needed. May oversee activities of junior regulatory personnel and manage contractual and budgetary responsibilities with best business practices.
More about You
- BS or equivalent with 12 years of related experience
- Prior experience in labeling content development and maintenance required
- Prior experience in rare disease and accelerated approval products preferred.
- Experience working with and leading crossfunctional teams.
- Working understanding of registration dossiers
- Excellent collaboration verbal and written communication skills
- Strong interpersonal skills and the ability to influence others without authority.
- Excellent organizational and negotiation skills
- Ability to evaluate and recommend process improvement and suggest/implement best practices
- The ability to multitask prioritize and work under pressure in adhering to deadlines
- Proven ability to successfully manage projects and timelines organize/track complex information and prioritize accordingly
- Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details.
- Experience collaborating with stakeholders/partners at all levels globally across the organization
- Proficiency with Microsoft Office Applications (Word Excel Outlook) and other regulatory systems
What Now
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Required Experience:
Director
Employment Type
Full-Time
