The Director, Regulatory Affairs-Commercialization supports regulatory affairs activities related to commercial, medical affairs, and related compliance activities. In this role, you will ensure that advertising, labeling and promotional materials meet regulatory and company standards. The Director will be a regulatory lead for developing, enhancing and implementing department procedures to support preparation, review and approval of promotional and non-promotional materials for marketed and investigational products. The Director will be well versed in regulations related to these activities and be able to advise the company on strategies that will meet business objectives in a compliant manner.
- Reviews promotional and medical affairs materials and provides alternative solutions, when appropriate.
- Develops collaborative relationships with internal stakeholders, external regulatory agencies and experts
- Strategically assess risks and benefits of promotional and non-promotional communications; advise on risk parameters and offer potential solutions to achieve business objectives while maintaining compliance.
- Clearly and efficiently analyze issues and communicate options in the face of ambiguity.
- Ensure compliance of promotional materials with governing FDA regulations, and ensure timely submission of promotional materials to OPDP. Serve as the contact with OPDP as assigned.
- In collaboration with Medical Affairs, Legal and Compliance, support the development, improvement and implementation of procedures to support the preparation and approval of communication materials for marketed and investigational products.
- In collaboration with project teams and regulatory personnel, provide input on assigned draft product labels and core data sheets for products in development; oversee labeling for marketed products.
- Prepare and deliver effective presentations for external and internal audiences, including training, as needed.
- Maintain knowledge and monitor changes in pertinent laws, regulations and guidance documents. Interpret external developments and inform/educate stakeholders on potential implications for the company and products.
- A minimum of a Bachelor’s degree in a scientific discipline required. A Master’s or Doctorate degree preferred.
- At least 5 years’ experience in Regulatory Affairs in the Pharmaceutical or Biotechnology industry with a proven track record in implementing regulatory strategies for labeling, advertising and promotional regulatory functions.
- Experienced at interacting with OPDP from a strategic and operational perspective.
- Experienced with development stage products and supporting product launch(s).
- Well-developed critical reasoning skills and in risk management assessments.
- Excellent team interaction skills along with demonstrated ability to work in a cross functional team and influence decisions of a team.
- Demonstrated ability to work in a dynamic cross-functional team environment with a high degree of flexibility within constraints of compliance.
- A roll-up your sleeves style is essential.
- Demonstrated ability to function as an individual contributor and transition to managing a group as the company grows.
- Strong written and verbal communication skills and ability to give effective presentations, including training.
- Experience with partnerships/co-marketing arrangements, working with electronic systems (e.g., Veeva), and working knowledge of ex-US promotional regulations preferred.