Senior Regulatory Affairs Manager, Europe

Company Description

Abb Vie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

For more information about Abb Vie, please visit us at www. abbvie. co. uk.

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Job Summary

We are now recruiting a Senior Regulatory Affairs Manager, Europe supporting the Europe region and reporting to the Regulatory Affairs Director, Europe for Neuroscience & Specialty.

By joining Abb Vie you will play a pivotal role in the implementation of regulatory strategies and deliverables for a portfolio of assets in early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) team, including EU countries and non‑EU countries such as Israel, Turkey, Switzerland and the UK.

You will identify and advocate the region's requirements in the overarching global regulatory strategy, and develop risk assessment for project(s) and ensure they are considered at the Global Regulatory Product Team (GRPT).

• Main Accountabilities
• Products
• Works independently, informs line manager.
• Provides clear and constructive Europe Region (Area) regulatory input and intelligence to Area and Global Regulatory & Development Project Teams via the Area and/or Global Regulatory Lead (GRL) in accordance with Area & Commercial objectives.
• Ensures planned drug development activities comply with Area guidelines and if they do not, provide a critical analysis of the risks and issues with a remediation proposal.
• Defines regional strategy and supports global product development strategy(s); outlining options for Scientific Advice/PIP/orphan designation/Accelerated regulatory pathways.
• Coordinates preparation of briefing packages and lead agency meetings.
• Defines Europe Region filing strategy (including CP, MRP, DCP); identifying risks and issues.
• GRPT & ARPT representative ensuring regulatory requirements/interests of Area and Affiliates are represented at GRPT.
• Drives and leads regulatory activities in support of lifecycle management and maintenance in the region. Identifies compliance risks proactively.
• Supports co‑ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product‑related packaging as required to ensure regulatory compliance.
• Responsible for ensuring effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.

Ensures effective planning and tracking of activities via RIM system.

• Supports the communication of regulatory strategy in support of new product registration, in line with commercial objectives.
• Builds strong and effective relationships with Area, Affiliate & Global regulatory & cross‑functional teams to ensure Area and local RA activities are in line with regional business priorities.
• May be required to mentor less experienced staff as needed.
• Follows core Global and Area Regulatory policies and procedures.
• Supports development and implementation of new processes and ensures that these meet regional regulations and needs.
• Provides input into development of processes and supports implementation, as required.
• Responsible for the notification of Regulatory activities and related database entry/data accuracy for allocated projects.
• Responsible for ensuring forecasts are developed and actuals managed in line with regional requirements and communicating these to GRL and R&D finance for assigned projects.

Qualifications

Education and Experience

• Graduate in pharmacy, biology, chemistry, pharmacology or a related Life Sciences subject.
• Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
• Pharmaceutical industry experience in European Regulatory strategy development and regulatory procedures (including CP/DCP/MRP).
• Experience of EU strategy for development assets (e. g. scientific advice, paediatric investigation plans).

Essential Skills and Abilities

• Excellent organisational skills and solution‑driven leadership style.
• Ability to prioritise and manage workload including managing multiple projects.
• Ability to work effectively and collaboratively across the Abb Vie organisation.
• Experienced in working effectively across cultures and in a complex matrix environment.
• Good interpersonal and negotiation skills and the ability to influence others.

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

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