Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Description
Main Purpose of Job
* Define and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds (early development, late development, marketed) for the Europe Region.
* Identify and advocate region’s requirements in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is considered at the GRPT.
* Line management of team of Senior Regulatory / Regulatory Affairs managers.
* Primary RA interface with Commercial Area and in collaboration with the RA personnel in the affiliates.
Main Accountabilities
* Define and implement regulatory strategies and deliverables for early and late development compounds and marketed products with significant development activity in the assigned Therapeutic Area for the Europe Region.
* Identify and advocate region’s requirements in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is considered at the GRPT, LRST and other appropriate forums.
* Effectively lead planning, preparation and delivery of complex submissions / development programmes from regional perspective working in a matrix leadership environment.
* Assess scientific data provided by specialist units for development activities (e.g., scientific advice, special designations and registration purposes) against Europe regulatory requirements, identifying gaps and developing mitigation strategies.
* Develop a Local Regulatory Strategic Plan in collaboration with the RA personnel in the affiliates to elaborate the region’s position on specific projects. Act as ARPT lead.
* Primary RA interface with Europe Market Access and Medical Affairs for early touch points and represent RA in Area Brand Team (ABT) as applicable to provide strategic input for regulatory approval.
* Manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers as applicable. Receives delegation to manage EU agency hearings.
* Provide leadership and support to RA personnel in the affiliates (through ongoing communication, assist in the development, training and mentoring of regulatory leaders).
* Maintain an active awareness of EU and non‑EU legislation and assess its impact on AbbVie business and R&D programs jointly with RPI.
* Ensure regulatory compliance within Europe for assigned compounds/products and implement remediation plans to address identified gaps.
* Line management of a team of Europe Area Regulatory professionals and mentoring and coaching to other members of the team.
Accountability
* The incumbent’s decisions can affect sales, marketing, supply chain and clinical trials.
* The incumbent’s decision can affect the company’s image and credibility towards regulatory agencies.
* This position reports to the assigned TAH Europe Regulatory Affairs, GRS.
* Strategic input to assigned compounds/products in the context of the Europe geography.
* Cross‑functional team member responsibilities.
General Accountabilities
To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd. Identifies resource needs and tasks within business priorities.
Responsible for the health, safety and environmental performance of themselves and others through compliance within EHS programs, regulations and standards. Subject to the policy and procedures outlined in the EHS Handbook.
Qualifications
* Extensive pharmaceutical industry experience in Regulatory Affairs or R&D, with experience in designing, implementing & leading RA strategy & Agency interaction for development and life cycle management for the Europe region.
* Experience working in more than one therapy area with preference for immunology.
* Experience in leadership of complex programmes with matrix reporting.
* Recent experience of managing agency meetings.
* Recent line management experience.
* Experience working effectively across cultures and in complex matrixed environments.
* 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 organizational skills.
* Understands business needs and impact of regulatory issues on these.
* Sensitivity to Europe culture and ways of doing business is helpful.
* Implements the AbbVie ways of working.
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.
Seniority level
Mid‑Senior level
Employment type
Full-time
Job function
Legal
Industries
Pharmaceutical Manufacturing and Biotechnology Research
Location
Guide Post, England, United Kingdom
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