Senior Director, Regulatory Affairs Labeling

Proclinical is currently recruiting for a Senior Director of Labelling and Global Regulatory Affairs with a leading biopharmaceutical company located in Princeton, NJ. As the Senior Director, you will be responsible for the development and maintenance of the Target Product Profiles (TPPs), Company Core Datasheets (CCDS), and regional labeling to lead the strategic development and subsequent submission, launch, and post approval maintenance of clinical and globally marketed products.

Job Responsibilities

• Lead the development and implementation of Corporate and Department structures, procedures, and policies for the development of global labelling.
• Ensure effective planning of all cross-functional labelling activities.
• Drive labeling strategy in partnership with the Global Regulatory Lead and Country Liaisons in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, internal processes, and competitor analyses) for global labelling.
• Lead efforts to create, modify, and review global labeling documents, including target product profiles, company core data sheets, prescribing information, patient labeling, and packaging/artwork content.
• Coordinate labelling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality.
• Coordinate response to labelling-related questions from authorities and convenes labeling working group meetings to reach content consensus with technical experts.
• Responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in labelling activities and communications.
• Responsible for continuous quality and compliance throughout the packaging labeling process
• Participate in / Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.
• Prepare presentations and trains other departments and outside speakers.
• Member on project teams and regulatory sub-teams, as appropriate.
• Identify opportunities to influence regulatory policy and climate with respect to labelling content.

Skills and Requirements:

• Bachelors or Master's degree in a scientific discipline or equivalent. Advanced degree and/or RAC certification preferred.
• Minimum 8-10 years of regulatory affairs labeling experience with drugs and biologics, gene therapy experience preferred.
• Extensive knowledge of global regulations, guidance documents, and initiatives related to labeling requirements.
• Experience with executing creative labeling strategies for drugs and biologics development programs.
• Proven ability to understand regulatory implications of product strategy related to labeling development, assessment and management.
• Ability to assimilate clinical and scientific information and present it in a concise manner.
• Must be able to innovate, analyze, and solve problems with minimal supervisory input.
• Experience developing teams and managing direct reports and/or vendors.
• Strong communication skills (oral, written, and interpersonal) and the ability to proactively identify and recommend solutions to problems.
• Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
• Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making.
• Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
• Must have a solid understanding of FDA regulations and ICH guidelines, as well as comprehensive experience in the drug development process.
• High level of attention to detail and accuracy, and proficient with all Microsoft Office applications, Adobe and document management templates.

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 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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