Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter experts and Global Regulatory Leads (GRLs). The position requires management of multiple assigned products, including early and late-stage assets with differing levels of complexity. This position partners with other personnel including Regulatory, Clinical Development, Drug Safety, and Quality in support of development and maintenance of labeling content and contributes to health authority negotiations as necessary.

Responsibilities

• Acts as point of contact for cross-functional teams on local and global labeling issues. Manages labeling development or approval. Preparation of updated Core Data Sheets and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides). Independently leads cross functional teams through all labeling discussions with the FDA while ensuring management alignment. Strategizes and plans for FDA meetings as needed. 
• Conduct Label Committee Meetings: Prepares documents for review by labeling teams and labeling committee. Leads review processes and ensures appropriate governance for review of labeling documents.
• Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages compliance with internal and external guidelines, with regard to both content and format of labeling. Follows internal processes for record keeping and tracking of labeling milestones.
• Establish Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Leads the continuous improvement in process, including enhancement of Standard Operating Procedures (SOPs).
• Department Coordination: Builds cross-functional relationships.
• Leads development of the labeling strategy for multiple products and indications.
• Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across therapeutic areas.
• Provides strategic advice and guidance to cross-functional partners and stakeholders.
• Oversees and guides review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories.
• Develops and maintains target labeling documents for early phase products, in collaboration with GRL and product teams. Maintains an understanding of competitive landscape in assigned disease areas and opportunities for strategic differentiation. 

Skills:

• High level of applied knowledge of applicable FDA laws, regulations, guidance, and industry standards.
• In depth understanding of clinical trial design and interpretation of clinical data. 
• Strong interpersonal skills, strong communication skills (written and verbal).
• Ability to communicate complex issues clearly and concisely.
• Shape and develop strategies based on emerging trends.
• Ability to communicate business issues across all levels of the organization, negotiate business decisions, and work toward solutions to drive compliance.
• Significant experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products.
• Proven track record in effectively setting and directing the regulatory labeling or related strategy to successful conclusion for one or more products.
• Significant experience working with a broad array of regulatory labeling documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products.
• Significant experience in NDA/BLA labeling and labeling negotiations.
• Strong track record of successes working and negotiating with regulatory authorities.
• Extensive experience participating in cross-functional projects and teams.

Qualifications

Basic Requirements:

• Bachelor’s degree in a health or science-related field and/or an advanced degree.
• 10 or More Years pharmaceutical industry experience

• 5 or More Years of direct regulatory affairs experience, including US labeling experience required

  The annual base salary for this position ranges from $220,000 to $233,000. In addition, this position is eligible for an annual performance pay bonus.  Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.  Additional details can be found on our careers website: www.alkermes.com/careers#working-here  

  #LI-HB1

  About Us

  Why join Team Alkermes?

  Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

  Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). 

  
  

  Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law.  Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.

  PDN-9fc93e07-0753-4d57-9d8d-a7f963f1291a