Area Product Lead, EEMEA Regulatory Affairs, RAI

☞ ABBVIE

View: 106

Update day: 01-06-2024

Location: Maidenhead South East

Category: Pharmaceutical / Chemical / Biotech Science Labor

Industry: Pharmaceutical Biotechnology

Job type: Full-time

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Job content

About AbbVie
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.


Area Product Lead, EEMEA Regulatory Affairs, RAI

Based in Maidenhead, reporting to the Therapy Area Head, Medical Aesthetics and Eye Care.

Highlighted responsibilities:

  • Define and implement Area & Affiliate regulatory strategies & deliverables for development compounds and marketed products in the defined Therapeutic Area for the EEMEA Area (including Russia, CIS, CEE, Adria, Middle East and Africa). In alignment with the overarching global regulatory strategy and in collaboration with the RA personnel in the affiliates.
  • Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met.
  • Develop a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RA personnel in the affiliates utilising the Area Regulatory Product Team (ARPT) meetings.
  • Assess scientific data provided by specialist units for registration (and re-r) purposes against EU and EEMEA regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data and development of complete and timely responses.
  • Maintain an active awareness of EU and EEMEA legislation and assess its impact on AbbVie’s business and R&D programs jointly with Regulatory Intelligence. Develop and execute strategies to respond to those. Propose revisions. Ensure application of policies once established.
  • Provide Area input on local implications through participation in Teams as needed (e.g., submission teams, labeling working group: development of labelling negotiations).
  • Ensure regulatory compliance within EEMEA for assigned compounds/products and implement remediation plan to address identified gaps, if any.

Qualifications


Qualifications & experience:

  • Extensive pharmaceutical industry experience in Regulatory Affairs or R& D, with experience in Regulatory Affairs. European and EEMEA Area regulatory experience (including Russia, CIS, CEE, Adria, Middle East and Africa) is a must
  • Knowledge of legacy Allergan products and development programmes is an advantage
  • Experience working effectively across cultures and in complex matrixed environment.
  • Strong project manager, excellent organisational skills and solution driven style
  • Proactive verbal and written communication style at all levels.
  • Ability to work independently with minimal supervision.
  • Strong interpersonal, managerial and organizational skills.
  • Understands business needs and impact of regulatory issues on these

#LI-CP1



Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
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Deadline: 16-07-2024

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