Associate Director, Regulatory Labeling

Apellis Pharmaceuticals • Waltham, MA

288d

About The Position

The Associate Director, Regulatory Labeling, will be responsible for initiating, leading, reviewing, and approving labeling strategies to ensure compliance with product registrations and regulatory requirements worldwide throughout the product lifecycle. Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new regulations, guidance documents, and enforcement letters. The Associate Director will train teams on regulatory issues pertaining to product labeling and will work cross-functionally in the development and implementation of labeling for Apellis' product portfolio that supports the achievement of business objectives.

Requirements

• Doctorate, Master's, or Bachelor's degree in a life science field (graduate degree preferred)
• At least 8 years experience in pharmaceutical or biotech industry in multiple phases of development, with extensive experience (at least 5 years) in regulatory labeling.
• Extensive knowledge of global regulations and standards particularly related to labeling; experience working with FDA, EMA, and other regulatory authorities worldwide.
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
• Proficient computer skills; able to use standardized office software products, such as Microsoft Word, Excel, PowerPoint, SharePoint, SmartSheets etc.
• Effective interpersonal with strong organizational skills and ability to effectively communicate and coordinate discussions to influence across all business functions to reach resolution on labeling topics.
• Strong writing, project management, and communication skills.

Responsibilities

• Lead the development, review, approval, and implementation process for target product profiles (TPPs), core data sheets (CDSs), country-specific labels, and other labeling documents.
• Organize and lead cross-functional labeling teams to discuss labeling strategy, reach consensus on global labeling matters, assess impact of regional/local labeling changes on the CDS and vice versa, and assist with the preparation of high-quality documents to support the creation of the CDS and/or changes to the local labeling for assigned development projects or marketed products.
• Prepare and manage international labeling including tracking differences in local labels to the CDS, ensuring local requirements are met, and translations are properly executed.
• Participate in labeling negotiations with global regulatory agencies resulting in product approvals or labeling updates and release of labeling for use throughout the company. Lead the preparation of responses to labeling-related queries from health authorities.
• Track data sources supporting labeling claims, history of labeling negotiations and changes, and reasons for differences in local labeling. Maintain and track labeling documents in the labeling repository and electronic system as appropriate.
• Coordinate labeling activities (e.g. labeling supplements, new labeling development) with external partners as required.
• Support the growth of the Regulatory Labeling function and help design/improve systems and processes.
• Maintain current awareness of evolving global labeling regulations and interpretations, advisory comments, enforcement actions and policy issues affecting the pharmaceutical industry. Provide strategic input on interpretation and implementation of key regional labeling regulations, guidelines, and best practices.
• Perform other duties as required.

Benefits

• 401(k) plan with company match
• Inclusive family building benefits
• Flexible time off
• Summer and winter shutdowns
• Paid family leave
• Disability and life insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Master's degree