Associate Director, Reg. Labeling Ops. and Compliance

Proclinical is seeking a remote Associate Director, Regulatory Labeling Operations and Compliance for a leading biotech company.

Must be eligible to work in the US.

Job Responsibilities:

• Strong independent self-starter willing to be flexible and participate in the development and execution of global labeling strategies for artwork and packaging components in collaboration with RA Regional Lead, Cross functional teams and GRA Labeling.
• Ability to mentor Junior team members and lead cross functional teams on core labeling and packaging requirements.
• Assist and mentor teams on Labeling operations and Compliance related tasks (proofing/tracker management/SP/VVS/Smart sheet).
• Liaise with Global Project Management (GPM) to ensure that project timelines for assigned regions support the coordination and assist with preparation of timely regulatory submissions.
• Coordinates with submission team to identify and provide all packaging components related to Module 1 documents to be included within submission content plans.
• Manage internal labeling repositories (VVS and SP) and ensure all labeling related materials are appropriately stored/managed.
• Recommend concise labeling language for inclusion on product label packaging per regulations and consistent with information in the regional/local labeling source files; obtain input and approval from all relevant functional areas.
• Prepare and provide final artwork mock-ups reflecting outcome from SME reviews in final labeling artwork prior to submission to local HA.
• Ensure regulatory labeling artwork components are in accordance with local Health Authority (HA) requirements and content reviews and QC checks are performed for all labeling, including artwork/inserts/Instructions for Use.
• Leading the regulatory evaluation of change control requests and participates in discussions for change controls related labeling impact for assigned regions, provide regulatory input for planned and ongoing changes, support risk assessment of the change controls.
• Assist with Change Controls, CAPAs and help team with Process Deviation logs.
• Ensure labeling history logs and Deviation logs are UpToDate and signed off by relevant management teams and managed appropriately in electronic repositories.
• Help GPM Track all labeling submissions and approvals on a routine basis.
• Ensure Timeline deferral and Content Deviation forms are appropriately tracked and maintained in electronic repositories.
• Act as regulatory labeling representative on internal workstreams/project teams.
• Contribute to and manage key supporting documents for labeling updates (e.g., summary of changes documents, justification documents, HA response documents)
• Review SCPs, CLs and Published outputs for labeling.
• Analyze relevant competitor labeling to ensure the most competitive label packaging is possible; maintain awareness of recent trends and industry practice and monitor class approval changes that impact product packaging.
• Contribute to the development and review of Standard Operating Procedures, Work Instructions, Job aids, QC checklists to ensure continuous improvement of the global labeling program and compliance.
• Assist with responses to Health Authority inspection related questions related to artwork and packaging.
• Participate in training regulatory and labeling review teams on relevant labeling policies and procedures, as needed.
• Flexibility and Willingness to assist team with QC and other tasks across both Labeling Strategy and Operation is a must.

Skills and Requirements:

• Bachelor's degree preferably in a scientific field. An advanced degree is desirable.
• A minimum of 10 years in the drug development industry with 4-6 years in Global Regulatory Affairs with focus on labeling operations and compliance.
• Pharmaceutical industry knowledge across key functional areas relevant to labeling (Global Labeling Operations, Manufacturing, Quality Assurance, Supply Chain, Advertisement and Promotional Review, and Marketing).
• Must be available to work remotely during Core working hours EST.
• Possesses and understanding of the drug development process and global regulatory environment.
• Knowledge of global/regional regulations and guidelines pertaining to labeling artwork and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions.
• Strong communication skills (oral, written, and interpersonal); critical-thinking and ability to identify and recommend solutions to problems.
• Attention to detail and strong proofreading skills.
• Familiarity with eCTD file structure and referencing data within eCTD Modules highly desired.
• Experience using an electronic document and artwork management systems is highly desired.
• Flexible and willing to work in a dynamic and fast-paced environment while managing multiple priorities.
• Shows strong initiative and drive. Must be an organized self-starter.
• Proven ability to work well both within a team and independently and interact effectively across cross-functional departments; proactive and communicative.
• Familiarity using documentum (VVS/any EDMS) and other electronic task and artwork management systems.
• Ability to embrace a culture of learning and growth.

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at +(1) 617-963-0342 or f.gbadamosi@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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