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AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Regulatory Manager, Europe

Maidenhead, England, United Kingdom Req ID 2201025 Category Regulatory Affairs Division AbbVie
  • MAIN PURPOSE OF JOB

  • Design and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds typically late development, marketed for the WE Area (including Israel, Turkey and Switzerland) . Include fair representation of the interest of EU countries of EMEA.. In alignment with the overarching global regulatory strategy and region specific requirements.
  • Identify and advocate region’s requirements in the overarching global regulatory strategy ; develop risk assessment of the project(s) and make sure it is taken into account at the GRPT.
  • Primary RA interface with Commercial Area. and in collaboration with the RA personnel in the affiliates.
  • Primary interface to and from the RA personnel in the affiliates.
  • MAIN ACCOUNTABILITIES

  • Design and implement regulatory strategies & deliverables typically for late development and marketed products in the assigned Therapeutic Area for the WE Area (including Israel, Turkey and Switzerland). In alignment with the overarching global regulatory strategy and region specific requirements.
  • Identify and advocate region’s requirements in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is taken into account at the GRPT.
  • Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met. Duly reports on activities in these teams and alerts TA Head when necessary.
  • Elaborate a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RA personnel in the affiliates. (Area Regulatory Product Team ARPT) to elaborate the region’s position on specific projects.
  • Primary RA interface with Commercial. Represent RA on the Brand Teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product).
  • Primary interface to and from the RA personnel in the affiliates.
  • Primary interface with local health authorities (via RA personnel in the affiliates).
  • Responsible for direct liaison with EMA for products within the Therapeutic area. Receives delegation to manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers.
  • Provide leadership and support to RA personnel in the affiliates (through ongoing communication, assist in the development, training and mentoring of regulatory leaders).
  • Assess scientific data provided by specialist units for registration (and re-r) purposes against WE regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses (including CTAs).
  • Maintain an active awareness of EU legislation and assess its impact on AbbVie business and R&D programmes jointly with RI. Develop and execute strategies to respond to those. Propose revisions. Ensure application of policies once established.
  • Implements  the EU processes to achieve local HA input into R&D Programmes and regulatory approval.
  • Provide Area input on local implications through participation in Teams as needed (e.g., submission teams, labelling working group: development of labelling negotiations).
  • Ensure regulatory compliance within WE for the assigned compounds/products. Implement remediation plan to address identified gaps, if any.
  • ACCOUNTABILITY
  • The incumbent’s decisions can affect sales, marketing, supply chain and clinical trials.
  • The incumbent’s decision can affect company’s image and credibility towards regulatory agencies.
  • This position reports to the assigned TAH, Director, WE, Regulatory Affairs, PPG and may report to an Associate Director.
  • Strategic input to assigned compounds/products in the context of the WE geography
  • Cross-functional team member responsibilities.

BACKGROUND/EDUCATION

  • Pharmaceutical industry experience in Regulatory Affairs or R& D, with experience in Regulatory Affairs. European regulatory experience (including Israel, Turkey and Switzerland).
  • Experience working effectively across cultures and in complex matrixed environment.
  • Proactive verbal and written communication style at all levels.
  • Strong leadership presence and solution driven style.
  • Ability to work independently with minimal supervision.
  • Demonstrated success in negotiating skills.
  • Strong interpersonal, managerial and organisational skills.
  • Understands business needs and impact of regulatory issues on these.
  • Percent of Travel: 25% at least.
  • Sensitivity to WE culture and ways of doing business is helpful.
  • Implements the AbbVie way of doing business.
  • A Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
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