Director Regulatory Affairs, Global Advertising And Promotion (Medical Device And Pharmaceutical)

7+ years

Not Disclosed

Remote, USA

10 Nov. 20, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director of Regulatory Affairs, Global Advertising and Promotion

At Baxter, our mission is deeply rooted in saving and sustaining lives. No matter your role, you make a meaningful impact on patients worldwide. Our products and therapies are found in hospitals, clinics, and homes, touching the lives of millions. For over 85 years, we have pioneered medical innovations that transform healthcare, and together, we create a workplace that’s both successful and inspiring.

This is where you can do your best work—at the intersection of saving lives and advancing our mission.

Your Role at Baxter:

As the Director of Regulatory Affairs, Global Advertising and Promotion, you will lead the strategic direction and execution of the Regulatory Advertising and Promotion (AdProm) Team within Global Regulatory Affairs (GRA). This includes overseeing the development, submission, and compliance of advertising and promotional materials, as well as Company Core Data Sheet (CCDS) labeling activities, ensuring alignment with business objectives and regulatory requirements.

What You’ll Be Doing:

Leadership & Strategy:
Lead and provide vision for the AdProm team, developing and implementing strategies that ensure regulatory compliance and meet business needs across various functions. You will oversee and manage a team, ensuring the delivery of quality regulatory services and fostering an environment of collaboration and innovation.
Regulatory Compliance & Coordination:
Guide the team in navigating complex regulatory requirements for advertising, promotion, and labeling. Develop standardized processes for advertising and promotional materials, ensuring they align with business strategies and regulatory guidelines.
Team Management & Development:
Manage a geographically dispersed team, developing talent and fostering a high-performance culture. Provide clear goals, mentorship, and coaching to direct reports while nurturing their career growth.
Labeling Oversight & Vendor Management:
Ensure seamless coordination for CCDS and labeling activities managed by external vendors, maintaining high standards of quality, accuracy, and timeliness.
Stakeholder Engagement & Collaboration:
Collaborate with internal partners, including Marketing, Medical Affairs, Legal, and other regulatory sub-functions, ensuring effective communication and regulatory support across projects.
Regulatory Advocacy & External Representation:
Represent Baxter in external industry groups and forums related to regulatory affairs, influencing policies and regulations in advertising and promotional practices.
Metrics & Performance:
Establish key performance indicators to measure and improve team performance. Use data to drive continuous improvement in processes and capacity building.
Budget & Resource Management:
Oversee budgeting and forecasting for the regulatory function, ensuring resources are allocated efficiently to meet departmental and organizational goals.
Quality & Process Improvement:
Lead quality improvement and continuous process optimization initiatives related to advertising and promotion regulatory practices.

Your Team:

The Director of Regulatory Affairs, Global Advertising and Promotion will report to the Senior Director of Global Strategy & Delivery and will manage a team of 12 professionals across the US, Canada, and the UK. The team works collaboratively with cross-functional teams, including Marketing, Legal, and Medical Affairs.

Your Location:

This role is based at Baxter’s global corporate headquarters in the northern suburb of Deerfield, Illinois, with flexible work options available through our workplace policy. Alternatively, the role may be based at our facilities in Batesville, IN; Raleigh, NC; St. Paul, MN; Skaneateles Falls, NY; or Mississauga, ON. Relocation assistance to the greater Chicago area is provided.

What You’ll Bring:

Education: Bachelor’s degree in Biotechnology, Pharmacy, Life Sciences, or a related field.
Experience:
- Minimum 10 years of experience in Regulatory Affairs within the medical device or pharmaceutical industries.
- At least 7 years of experience specifically in Advertising and Promotion (AdProm).
- Proven track record in managing teams and strategic regulatory programs.
- Familiarity with mergers and acquisitions, labeling content management, and CCDS activities is preferred.
- Experience using Veeva PromoMats is a plus.
Leadership & Influence:
- Strong leadership and people management skills with experience developing high-performing teams.
- Ability to influence internal stakeholders and external regulators, driving policy and regulatory decisions.
- Strategic thinker with the ability to manage regulatory risk and complexity in a fast-paced environment.
Global Experience:
- International experience and exposure to global regulatory frameworks is preferred.
- Ability to effectively manage relationships with both internal teams and external business partners.
Skills:
- Proficiency in regulatory affairs processes and ability to communicate complex regulatory issues in a clear, concise manner.
- Strong decision-making, strategic planning, and operational skills.

Compensation:

The estimated base salary for this position is $160,000 - $220,000 annually, depending on experience, skills, and location. This range reflects an anticipated salary for the position, with the potential for additional bonuses and long-term incentives. For further compensation details, please consult with the recruiter during the interview process.

Equal Employment Opportunity:

Baxter is an equal opportunity employer and evaluates applicants without regard to race, religion, gender, national origin, age, sexual orientation, disability status, or any other legally protected characteristic. We value diversity and are committed to fostering an inclusive work environment for all employees.

Reasonable Accommodations:

Baxter is dedicated to providing reasonable accommodations for individuals with disabilities. If you require accommodations during the application or interview process, please let us know.

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Director Regulatory Affairs, Global Advertising And Promotion (Medical Device And Pharmaceutical)

Job Description

Your Role at Baxter:

What You’ll Be Doing:

Your Team:

Your Location:

What You’ll Bring:

Compensation:

Equal Employment Opportunity:

Reasonable Accommodations:

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