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 AbbVie 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.

2. People

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

Processes

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 AbbVie organisation.

Experienced in working effectively across cultures and in a complex matrix environment.
Good interpersonal and negotiation skills and the ability to influence others.

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:

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