The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing regulatory leadership and guidance for promotional, medical, and other external communications while supporting the development and maintenance of product labeling for assigned products. Reporting to the SVP, Regulatory Affairs, this role serves as a key regulatory partner to internal teams to ensure promotional communications and labeling activities comply with applicable regulatory requirements while supporting business objectives.
DUTIES AND RESPONSIBILITIES: - Lead the promotional material and labeling strategy and activities for assigned products and therapeutic areas.
- Provide regulatory guidance and manage regulatory aspects of the review and approval for product promotional materials and labeling.
- Lead label working groups and promotional review meetings, as needed. Collaborate with cross-functional reviewers to determine next steps and approval status.
- Ensure that content, quality, accuracy, and format of submissions comply with applicable internal policies procedures as well as applicable regulatory guidance and requirements.
- Partner effectively with internal teams as needed to ensure thorough, timely and efficient review and completion of all materials.
- Provide guidance and expertise on new marketing concepts and promotions tactics for assigned products.
- Support interactions with Healthcare Authorities including discussions related to label negotiations, and promotional materials for advisory comments for full approval and accelerated approval products.
- Monitor evolving regulations, enforcement trends, guidance documents, and industry developments impacting promotional and labeling activities and communicate implication and recommendations to internal stakeholders.
- Other duties as assigned.
EDUCATION AND EXPERINCE:
- Bachelor's degree in life sciences or relevant field.
- 5+ years of experience in regulatory affairs in promotional materials, global labeling or related discipline.
- Strong understanding of FDA regulations and guidelines.
DESIRED KEY COMPETENCIES:
- Ability to understand and execute the company's mission and values.
- Self-motivated and independently minded.
- Strong verbal and written communication skills and cross-functional collaboration abilities.
- Self-organizer, meticulous hands-on habits, keen attention to detail.
- Ability to build working relations throughout the organization to achieve business goals.
- Strong time management, organizational, and execution skills.
- Ability to manage multiple projects in a fast-paced environment.
- Excellent judgement and decision-making skills.
- Problem solving and risk-mitigation skills.
