This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a
The Associate Director, Regulatory Labeling will be responsible for development and implementation of global regulatory labeling processes and strategies for all Arena products. Through cross-functional collaboration, he/she will provide tactical guidance to program teams, contribute to and maintain Target Product Labels, participate in label negotiations with Health Authorities, and develop and maintain US Prescribing Information (USPI) and EU Summary of Product Characteristics (SmPC) and other labeling documents. This position interfaces with product teams and requires comprehensive understanding of global labeling.
What you'll dive into
- Lead the labeling strategy for the development and lifecycle management of the CCDS, US, and EU labels considering labeling precedent, Health Authority feedback, and regulatory guidances.
- Provide regulatory guidance according to the assessment of approved product labeling, references, applicable regulations, and regulatory environment materials (i.e. enforcement actions, advisory comments, and guidance documents for the pharmaceutical industry, etc.)
- Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities and communicates the impact on Arena products to teams.
- Lead and coordinate engagement with cross-functional teams to develop, review, approve and maintain the CCDS, US and EU and global labeling and artwork for assigned products.
- Engage with cross-functional labeling stakeholders to arrive at consensus on labeling strategy.
- Participate in labeling negotiations with health authorities and recommend strategies in support of labeling negotiations.
- Effectively identify and encourage resolution of conflicts/issues to reach labeling decisions and proactively escalate issues to management, as necessary.
- Lead development and maintenance labeling process and procedures
- Interface with Regulatory Operations and other functions to prepare final proposed labeling for review by the Labeling Team and approval by the executive governance committees, as appropriate, prior to submission to health authorities.
- Prepare and maintain labeling documents and history for assigned products, including the Core and US labeling and their associated SPL (Structured Product Labeling), patient labeling documents, target product labels and artwork.
- Ensure compliant version control of product labeling and other related documentation within the document management systems.
What we expect
- Bachelor’s Degree required; advanced degree in health-related field (MSN, MPH, Pharm D, PhD, or equivalent) preferred
- 5 - 8+ years in Regulatory Affairs, R&D or related area within the pharmaceutical industry with.
- Knowledge of FDA and EU labeling requirements; some knowledge and experience with Japan and Emerging Markets labeling requirements desirable
- Demonstrated experience in development and life-cycle management of global labeling, from Target Labeling Profiles to the Company Core Data Sheet
- Experience working on cross-functional teams and within a global product development and labeling committee
What you’ll get:
- To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
- Opportunities to learn and contribute creative solutions
- Comprehensive health insurance
- Matching 401k retirement plan
- Paid time off and holidays
- Company celebrations
Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. I