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. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Associate Director – Regulatory Affairs (Neuroscience)

• Reporting to Therapy Area Head and located at Maidenhead offices (hybrid working)
• Excellent development opportunity in the Europe team
• Great benefits and career progression within role

Job Overview

• 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.
• 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.

Key Responsibilities

• Define and implement regulatory strategies and deliverables for early and late development compounds and marketed in Neuroscience
• 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
• Provide coaching and mentoring to Europe Area Regulatory Managers and Senior Managers

Qualifications

Experience Required

• 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
• Experience working in more than 1 therapy area with experience in neuroscience desirable but not essential
• Experience in leadership of complex programmes with matrix reporting.
• Recent experience of managing agency meetings
• 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
• A Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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https://www.abbvie.com/join-us/reasonable-accommodations.html