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Associate Director, Global Regulatory Affairs, Advertising and Promotion(m/w/x)
Regulatory guidance for global advertising and promotion materials, leading CMRP reviews for assigned products at an R&D-driven biopharmaceutical company. 8+ years pharmaceutical industry experience, 6+ years regulatory experience, and ABPI/EFPIA advertising codes knowledge required. Global project leadership for regulatory review processes.
Requirements
- BSc Degree or BA
- 8+ years of pharmaceutical industry experience
- 6 years of regulatory experience or 5+ years regulatory and/or related experience
- Understanding of ABPI, EFPIA and international advertising codes
- Experience in prescription medicine promotion development
- Strong interpersonal skills
- Ability to communicate clearly and concisely
- Effective written and verbal communication skills
- Proven negotiation and influencing skills
- Cross-functional people management skills
- Ability to work independently and meet deadlines
- Previous experience in advertising and promotion role
- Experience in regulatory affairs, particularly advertising and promotion
- Strong leadership and conflict resolution skills
- Strategic mindset for regulatory impacts assessment
- Guiding teams through advertising and promotion processes
Tasks
- Act as the Subject Matter Expert for assigned products and projects
- Provide regulatory guidance during the development and review of medical and commercial materials
- Serve as the Regulatory Advisor in the Medical, Legal, and Regulatory review process
- Lead global CMRP as the product or project business lead
- Chair CMRP meetings and facilitate communication among team members
- Negotiate and resolve team disputes while maintaining focus on patient needs
- Oversee escalation steps for alignment on new data or campaigns
- Partner strategically from clinical trial development through product marketing
- Provide expertise on EFPIA, IFPMA, and FDA codes and regulations
- Ensure compliance and patient safety within the CMRP
- Lead and motivate team members to achieve organizational goals
- Identify and implement processes for reviewing promotional materials
- Advocate for and implement positive change within the organization
- Analyze complex issues and propose effective solutions
- Communicate clearly and concisely in all interactions
- Adapt to various personalities to foster goal achievement
- Collaborate effectively in a cross-functional team environment
- Create and deliver impactful presentations with focused recommendations
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
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Associate Director, Global Regulatory Affairs, Advertising and Promotion(m/w/x)
Regulatory guidance for global advertising and promotion materials, leading CMRP reviews for assigned products at an R&D-driven biopharmaceutical company. 8+ years pharmaceutical industry experience, 6+ years regulatory experience, and ABPI/EFPIA advertising codes knowledge required. Global project leadership for regulatory review processes.
Requirements
- BSc Degree or BA
- 8+ years of pharmaceutical industry experience
- 6 years of regulatory experience or 5+ years regulatory and/or related experience
- Understanding of ABPI, EFPIA and international advertising codes
- Experience in prescription medicine promotion development
- Strong interpersonal skills
- Ability to communicate clearly and concisely
- Effective written and verbal communication skills
- Proven negotiation and influencing skills
- Cross-functional people management skills
- Ability to work independently and meet deadlines
- Previous experience in advertising and promotion role
- Experience in regulatory affairs, particularly advertising and promotion
- Strong leadership and conflict resolution skills
- Strategic mindset for regulatory impacts assessment
- Guiding teams through advertising and promotion processes
Tasks
- Act as the Subject Matter Expert for assigned products and projects
- Provide regulatory guidance during the development and review of medical and commercial materials
- Serve as the Regulatory Advisor in the Medical, Legal, and Regulatory review process
- Lead global CMRP as the product or project business lead
- Chair CMRP meetings and facilitate communication among team members
- Negotiate and resolve team disputes while maintaining focus on patient needs
- Oversee escalation steps for alignment on new data or campaigns
- Partner strategically from clinical trial development through product marketing
- Provide expertise on EFPIA, IFPMA, and FDA codes and regulations
- Ensure compliance and patient safety within the CMRP
- Lead and motivate team members to achieve organizational goals
- Identify and implement processes for reviewing promotional materials
- Advocate for and implement positive change within the organization
- Analyze complex issues and propose effective solutions
- Communicate clearly and concisely in all interactions
- Adapt to various personalities to foster goal achievement
- Collaborate effectively in a cross-functional team environment
- Create and deliver impactful presentations with focused recommendations
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
About the Company
Takeda Development Center Americas, Inc.
Industry
Pharmaceuticals
Description
The company is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide.
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