Associate Director, Global Regulatory Affairs, Advertising and Promotion

Job not on LinkedIn

August 14

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $153.6k - $241.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• Role: Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs/products as the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion. • Act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs. • Serve as 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. • Lead global CMRP program; Chair meetings, mediate disputes, negotiate as needed, ensure alignment and escalate when necessary. • Act as strategic business partner from clinical trial development through the marketing and maintenance phases of the product lifecycle. • Be Subject Matter Expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms. • Exercise decision-making authority within the CMRP to ensure compliance and patient safety; align with Takeda’s values. • Partner across product lifecycle for regulatory advice and risk assessment. • Strong leadership, negotiation, and cross-functional collaboration to drive compliant promotion.

🎯 Requirements

• 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. • 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. • Previous experience in an advertising and promotion role. • 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. • Leadership Skills can lead and motivate team members. • Develops, uses and shares knowledge and uses strong interpersonal skills to guide others toward 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.

🏖️ Benefits

• Short-term and long-term incentive plans • Medical, dental, and vision insurance • 401(k) plan and company match • Short-term and long-term disability coverage • Basic life insurance • Tuition reimbursement program • Paid volunteer time off • Company holidays • Well-being benefits • Up to 80 hours of sick time per calendar year • Up to 120 hours of paid vacation for new hires