Director, Regulatory Affairs Labeling

Our client is seeking a highly motivated and experienced individual for a Director position to lead and build a global labeling group within their Regulatory Affairs organization. This position will develop, manage, and execute global labeling strategy working in close collaboration with cross-functional teams across the organization in their Washington, DC location.

Job Responsibilities:

• Ensure commercial and promotional materials are consistent with guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.
• Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, CSI, USPI, SPC, other global labeling, and their associated Patient Labeling Documents. Engage in and contribute to Labeling Team discussions regarding these documents.
• Act as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirements and guidelines and company policies and procedures.
• Prioritize Labeling activities and set clear targets using project management tools to ensure internal and external deadlines are met. Identify and assist teams to overcome barriers in achieving quality and compliance.
• Communicate label update plans in a timely manner.
• Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
• Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.
• Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic areas.
• Provide strategic advice for the development of submissions to be sent to the Office Of Prescription Drug Promotion or Advertising and Promotion Labeling Branch.
• Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances.
• Lead training for Commercial teams on 2253 regulations and FDA regulations on advertising and promotion.
• Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.

Skills and Requirements:

• Knowledge of global/regional regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions.
• Able and willing to work in a fast-paced environment while handling multiple priorities.
• Shows strong initiative and drive. Must be an organized self-starter.
• Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree such as Pharm.D., Ph.D. are an advantage but not essential.
• A minimum of 12 years in the drug development industry with at least 10 years in Regulatory Affairs with focus on labeling expertise.
• Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
• Proven aptitude to analyze and interpret efficacy and safety data.
• Experience communicating and negotiating with APLB or OPDP.
• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
• Excellent written and verbal communication skills essential.
• Demonstrated project management skills and attention to detail required.
• Proven ability to negotiate, influence and problem solve across a highly matrixed team.

If you are having difficulty in applying or if you have any questions, please contact Nick Walker at (+1) 646-367-2908 or n.walker@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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