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.
Primary interface to and from 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. Duly reports on activities in these teams and alerts the TA Head when necessary.
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. Ensure effective presentation of data, complete and timely responses. Supports clinical trials strategy as required.
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, 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.

Responsible for direct liaison with EMA for products within the Therapeutic area. 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. Develop and execute strategies to respond to those. Propose revisions. Ensure application of policies once established.

Broadly applies regulatory/technical knowledge of regulations and skills across therapeutic areas and is generally recognized as a resource & subject matter expert (SME) for Regulatory.

Ensure regulatory compliance within Europe for assigned compounds/products. Implement remediation plan to address identified gaps, if any.

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.

BACKGROUND/EDUCATION

Extensive pharmaceutical industry experience in Regulatory Affairs or R&D, with experience in designing, implementing & leading RA strategy & Agency interaction for development (in activities pertinent to early stage through to late-stage development projects) and life cycle management for the Europe region. Centralised experience essential.
Experience working in more than 1 therapy area with experience in immunology preferred.
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 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 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.

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.

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Associate Director, Regulatory Affairs

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