Associate Director, Regulatory Affairs Advertising

3 weeks ago

Boston, United States Argenx SE Full time

Associate Director, Regulatory Affairs Advertising & Promotion page is loaded

Associate Director, Regulatory Affairs Advertising & Promotion

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locations

Boston

time type

Full time

posted on

Posted 4 Days Ago

job requisition id

REQ-2604

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 T his position is a hybrid role located in Boston, MA. #

LI-Hybrid At argenx we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us athr.us@argenx.com . Only inquiries related to an accommodation request will receive a response.

About Us

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland.

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