TakedaPharmaceutical Nordics AB · 6 hours ago
Associate Director, Global Regulatory Affairs, Advertising and Promotion
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
8+ years expTakeda Pharmaceutical Nordics AB is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. The Associate Director, Global Regulatory Affairs Advertising and Promotion will be responsible for managing assigned programs/products as the internal expert on US and international codes and industry standards pertaining to prescription medicine promotion.
Pharmaceuticals
Responsibilities
Act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs
Be the Regulatory Advisor and function as the 'R' in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). Provide regulatory guidance during development, review, approval, and implementation of medical and commercial materials
Be the product or project business lead for global CMRP at Takeda
CMRP Meeting Chair - pausing to communicate comments to coordinator, diffusing team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders which are the patients who trust us to do the right thing, and overseeing escalation steps if MLR cannot come to alignment or if there is new data or campaigns that require senior level management input or alignment
Serve as a strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle
Provide expertise on EFPIA, IFPMA, and FDA codes, regulations, guidance, industry standards, and innovative promotional platforms
Exercise decision-making authority within the CMRP to ensure compliance, patient safety, and alignment with Takeda’s values
Qualification
Required
You can understand ABPI, EFPIA and other international code and guidance about advertising and promotion for prescription medicines
Experience in prescription medicine promotion development and review process
Strong interpersonal skills with ability to demonstrate strategic and analytic thinking
Demonstrated ability to communicate clearly and concisely
Highly effective written and verbal communication skills to manage, motivate and drive decisions within teams
Proven skills in negotiation, influencing without authority and working diplomatically through conflict
Demonstrated cross-functional people management with a desire to foster a positive team culture
Ability to work independently, take initiative and complete tasks to deadlines
Proven experience and expertise in regulatory affairs, particularly advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards
Strong leadership, negotiation, and conflict resolution skills within cross-functional teams
Strategic mindset and ability to assess and advise regulatory impacts across the product lifecycle
Adept in guiding teams through complex advertising and promotion processes with a focus on patient safety and compliance
Preferred
BSc Degree, preferred. BA accepted
8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience
Previous experience in an advertising and promotion role
Leadership Skills can lead and motivate team members. Develops, uses and shares knowledge and uses strong interpersonal skills to guide others (both inside and outside the department) toward the accomplishment of Takeda's goals and objectives
Strategic Approach – ability to identify, create and implement processes for the review of Promotional and Disease awareness materials
Change Management — ability to identify, advocate and implement change positively for the organizations Demonstrates flexibility and the ability to accommodate change
Analytical and Problem-Solving Skills - Excellent ability to understand complex issues and propose achievable solutions
Communication Skills ability to express oneself clearly and concisely
Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Teamwork - the ability to work well in a highly cross-functional team environment
Presentation skills — create and deliver presentations with appropriate messaging and focused recommendations
Company
TakedaPharmaceutical Nordics AB
Takeda Pharma AB is engaged in sales marketing For USA
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase