Regulatory Affairs Manager, Advertising and Promotion
Ciao! At Dompé , our success is rooted in our team and our history. We are a private, rapidly growing global biopharmaceutical company. Founded in Milan, Italy, we have a 165-year legacy of medical innovation. Dompé’s rich history has greatly influenced its priorities today: to innovate for the benefit of patients facing both everyday wellness needs and rare conditions. Dompé operates in two strategic areas in select markets around the world: Primary Care, which includes prescription and over-the-counter products; and Biotechnology and Rare Disease, which recently expanded into the United States.
Today Dompé has 700 employees worldwide and we are excited to be rapidly scaling in the United States. Our R&D hub is currently based in Boston, and the commercial organization is housed in the San Francisco Bay Area.
YOUR ROLE AT DOMPÉ: REGULATORY AFFAIRS MANAGER, ADVERTISING AND PROMOTION
The candidate supports the Regulatory Affairs Director (HQ-Italy) and will play an important role within the Regulatory Affairs organization.
Your role is important! As one of the primary contact point for Regulatory Affairs in Dompé US, you will
- provide direction and oversight of regulatory advertising & promotion activities;
- provide leadership to help ensure that activities and communication are consistent with USPI and are in compliance with applicable laws, guidelines and Dompé policies;
- represent the Regulatory Affairs at PRC (Product Review Committee) and be responsible to revise, approve and submit materials for Dompé’s breakthrough therapy, the first-ever ophthalmic biologic product for patients suffering from a rare eye disease;
- direct the regulatory review of no-promotional scientific information, and external communication materials, including media information
- Improve the strategies for FDA promotional submission, working with both US and HQ team
- Maintain current awareness of evolving FDA and International regulation and interpretation, working closely with HQ.
You will also support HQ Regulatory Affairs department for preparing regulatory submissions for the assigned product such as post-approval supplements, annual reports and other reports.
We are seeking team members who will live by and promote the core values of our Dompé culture: Integrity, Speed, Knowledge, Passion, Attention to Detail, Reliability, Flexibility and Teamwork.
We are looking for individuals who possess an entrepreneurial spirit, flexible attitude, and adaptable nature to join our team.
WHAT YOU’LL BE DOING: MAIN RESPONSIBILITES
- To prepare high quality submissions according to timelines and guarantee regulatory compliance (Veeva RIM)
- To serve as Regulatory member of the Promotional Review Committee (PRC) which meets weekly
- To represent Regulatory Affairs in cross-functional team meetings
YOU COULD BE THE PERFECT FIT IF YOU HAVE:
Master Degree (MS/MA) Science, Technical - Preferred
Bachelors Degree (BA/BS) Science, Technical - Required
At least 4 years in regulatory affairs (with focus on promotional review of drug products, also outside US)
Previous experience with Veeva
To use good judgment when performing daily job activities, working in close collaboration with HQ Regulatory Affairs
SKILLS YOU’LL NEED FOR SUCCESS: TECHNICAL
- Review materials related to labeling, advertising and promotion of brand drug products and congresses
- Prepare and submit materials each week (eCTD: publishing and submission, coordinating with Reg. Operations)
- Supports regulatory compliance with internal SOPs and FDA requirements, including compilation and submission of any required documents to regulatory agencies
- Maintains up-to-date knowledge of laws, regulations and policies enforced by the FDA, as they relate to labeling, BLA, advertising and promotion of pharmaceuticals and provides regulatory advice accordingly
- Monitors impact of changing regulations on submission strategies and updates Regulatory HQ
- Preparation and submission of PAS, CBER30, Annual Reports, Amendments etc., managing submission timelines for the cross-functional team and tracking according to the company’s system
- Escalates issues to Regulatory HQ as appropriate
- Communicates with US Local Agent, consultants, attorneys and external parties as needed
SKILLS YOU’LL NEED FOR SUCCESS: PERSONAL
- Flexibility and use an approach based on the need and common sense in order to be a real problem solver.
- Excellent written and verbal communication skills, negotiation and interpersonal skills.
- Ability to communicate effectively and collaboratively as part of a team
- Time management, organization and planning skills, ability to prioritize activities.
- Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects and daily activities.
- Ability to work independently, self-starter.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.