Associate Director, Regulatory Affairs, Europe Regulatory Policy & Intelligence

Posted 13 Days Ago
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Hoofddorp, NLD
Hybrid
Entry level
Healthtech • Pharmaceutical
The Role
Leads European regulatory policy and intelligence activities for AbbVie, including monitoring policy and regulatory changes, analyzing business impact, developing company positions, and coordinating advocacy strategies. Builds relationships with health authorities, trade associations, peer companies, and regulators. Provides regulatory insights for drug development strategy, leads cross-functional responses to consultations, presents complex topics to senior leaders, and supports alignment with scientific, ethical, statutory, quality, and business requirements.
Summary Generated by Built In
Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Reporting the Head of Europe, Regulatory Policy & Intelligence.

Position Overview:

The Associate Director, Europe Regulatory Policy & Intelligence (RPI), will be a strong subject matter expert in regulatory policy and procedure, laws and regulations with a comprehensive understanding of how regulatory policy is shaped and developed within Europe, and the business context for R&D. Ability to assimilate policy trends in the European Union, and engage with impact, in the external environment is a key capability for this role. Policy experience in life science environment is required.

The role will address policy and intelligence assimilation, analysis of changes in the regulatory environment, development of policy positions and advocacy strategies to advance policy goals through internal and external collaboration. The individual will work closely with RA and cross functional colleagues to coordinate policies to ensure alignment with AbbVie portfolio priorities. 

The Europe RPI Associate Director develops, and maintains relations with HAs, peer company, and industry trade associations regarding scientific and regulatory policies, guided by company priorities. The role involves leadership of the development of cross-functional, multidisciplinary team responses to HA consultations, with a focus on aligning with company positions and scientific rigor.  Through the provision of intelligence insights, the Associate Director assists company to comply with scientific, ethical, statutory, quality, and business requirements.

Highlighted Responsibilities:

  • Independently manages and leads regional topics in the regulatory policy and intelligence function. Defines scientific and regulatory policy initiatives within assigned areas. A high level of proactivity and business acumen is required.
  • Serves as policy subject expert based on in depth knowledge of key regulatory issue and scientific basis. Analyses proposed policies with clear emphasis on communicating impact of trends. Leads formation of corporate position to share with trade associations, ensuring cross functional alignment.
  • Prepares and presents complex written and oral reports to Senior Management and external audiences on scientific and regulatory topics. Exceptional communication skills are needed to translate complex data into high-value insights.
  • Effectively uses negotiation skills to resolve policy issues when unable to agree internally.  Anticipates and communicates consequences of path chosen.
  • Serves as liaison to trade associations for management on scientific and regulatory issues.
  • Supports supervisor and Senior Management in discussions of complex policy topics at trade associations.
  • Contributes to regulatory product development strategy by responding to information requests and providing an analysis of the regulatory environment. 
  • Conducts external outreach with regulators, peers, and trades. Creates and responds to opportunities to enhance AbbVie’s relationship by participating in policy-related meetings. Utilizes local network of pharma companies to obtain policy-related information.

Qualifications

  • Degrees in Pharmacy, Chemistry, Biology, Relevant Master’s degree or PhD in a scientific, health, legal, or business discipline preferred.  
  • Proven experience with the pharmaceutical industry or with a health authority
  • Regulatory policy and intelligence experience, including experience with trade associations, either from work in the pharmaceutical industry or at a health authority.
  • Robust knowledge of healthcare regulations in support of drug development, including experience in interpretation. 
  • Experience working in a complex and matrix environment with demonstrated ability to assimilate policy trends, propose policy solutions with capability to influence internally and externally.
  • Exceptional communication skills are needed to translate complex data into high-value insights.
  • Well-established regulatory network across European countries
  • Experience with both medicines and medical devices would be an advantag

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Skills Required

  • Degree in Pharmacy, Chemistry, Biology, or a relevant master's degree or PhD in a scientific, health, legal, or business discipline
  • Proven experience in the pharmaceutical industry or with a health authority
  • Experience in regulatory policy and intelligence, including experience with trade associations, pharmaceutical companies, or health authorities
  • Robust knowledge of healthcare regulations supporting drug development, including regulatory interpretation
  • Experience working in a complex, matrixed environment
  • Ability to assimilate policy trends and propose policy solutions while influencing internal and external stakeholders
  • Exceptional communication skills and ability to translate complex data into high-value insights
  • Well-established regulatory network across European countries
  • Experience with both medicines and medical devices

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support — Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support — Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth — Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

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The Company
HQ: North Chicago, IL
56,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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