Title: Associate Director, Regulatory Affairs Advertising & Promotion
The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products ensuring they comply with US laws and regulations and company policies, while supporting achievement of business objectives. Provides regulatory review of advertising and promotional labeling, disease awareness and training materials, new campaigns, and product launch strategies.
Roles and Responsibilities:
- Serves as subject matter expert on FDA regulations and OPDP guidance governing promotion and prescription drug/ biologic products and disease awareness activities.
- Participates on multidisciplinary medical, legal and regulatory review team with individual responsibility for the review, risk assessment, and Regulatory decisions regarding product communications.
- Provides regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional and non-promotional materials assigned, including management of Form 2253 submissions.
- Ensures that US Prescribing Information (USPI) is accurately and contextually applied to relevant external communications and changes to USPI are incorporated within a timely manner.
- Monitors and keeps organization abreast on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance documents, relevant FDA enforcement action and general awareness of industry practices, including those of competitors).
- Contributes to culture of compliance at argenx by participating as needed in training argenx personnel on promotional, marketing, labeling and advertising regulations and updates.
Skills and Competencies:
- Ability to maintain collaborative, efficient, and effective working relations with cross-functional argenx teams (commercial, medical, legal and regulatory).
- Strong interpersonal, oral and written communication skills
- Understands business goals and common marketing concepts/tools
- High degree of professional ethics, integrity and responsibility
- Shows flexibility and is open to change in a growing, multi-cultural environment
- Capable of strategic thinking and proposing innovative solutions involving regulatory issues, while being a team player who invites response and discussion
- Comfortable in a fast-paced, results-driven, and highly accountable work environment
- Analytical and Problem-Solving Skills - ability to understand complex issues and propose achievable solutions
- Working knowledge of Veeva PromoMats
- This position is a hybrid role located in Boston, MA.
