Skip to main content

Search jobs

Search jobs

Over AbbVie

De missie van AbbVie is het ontdekken en leveren van innovatieve geneesmiddelen die vandaag een oplossing bieden voor ernstige gezondheidsproblemen en de medische uitdagingen van morgen aanpakken. We streven ernaar om een grote impact te hebben op het leven van mensen in verschillende belangrijke therapeutische domeinen: immunologie, oncologie, neurowetenschappen, oogzorg, virologie, vrouwengezondheid en gastro-enterologie, naast producten en diensten uit de portefeuille van Allergan Aesthetics. Bezoek www.abbvie.com voor meer informatie over AbbVie. Volg @abbvie op Twitter, Facebook, Instagram, YouTube en LinkedIn.

Senior Regulatory Manager, Europe

Maidenhead, Engeland, Groot-Brittannië Job ID 2201025 Categorie Regulatory Affairs Afdeling 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
ABBVIE

Meest recente vacatures

Aanmelden voor job alerts

Sluit u aan bij ons talentennetwerk en ontvang nieuws en job alerts van AbbVie in uw mailbox.

Geïnteresseerd inSelecteer een categorie of locatie. Klik op ‘Add’ (toevoegen) om uw job alert aan te maken.

Onze Gebruiksvoorwaarden, ons Cookiebeleid en ons Privacybeleid leggen uit hoe we uw gegevens verzamelen en gebruiken en wat uw rechten zijn. Door ons uw gegevens te verstrekken, verklaart u deze documenten te hebben gelezen en gaat u ermee akkoord dat AbbVie u sms-berichten en job alerts per e-mail kan toesturen.

Onlangs bekeken functies

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Click here to find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application