Regulatory Affairs Manager

In collaboration with line manager and/or Area Product Lead, is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs. May also support European regulatory strategy for assets in development.

Highlighted responsibilities:

Products

• 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.
• Ensure 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.
• Support global product development strategy(s); outlining options for Scientific Advice/PIP/IMPD, coordinating preparation of briefing packages and co-ordinating and leading agency meeting preparation.
• Prepare strategy recommendations to global regulatory and development teams in order to shape the global product strategy in line with Area regulatory and commercial objectives.
• Define & implement Area filing strategy (including CP, MRP, DCP); identifying risks and proposing mitigation.
• Lead, plan, conduct and implement regulatory activities in support of lifecycle maintenance in Area. Identify compliance risks and remediation activities proactively.
• GRPT & ARPT representative ensuring regulatory requirements/interests of Area & Affiliate are represented at GRPT.
• 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.
• Interface with EMA or Area Health Authority(s) for products within the Therapeutic Area on behalf of the Product Lead when required.
• Responsible for ensuring effective planning and tracking of activities, especially submissions and key correspondence. Ensures effective planning and tracking of activities via internal tools.

People

• Establishes strong and effective relationships with affiliates, area and global regulatory teams as well as cross-functional teams thereby ensuring RA activities are in line with regional business priorities.
• Potential to mentor less experienced Area regulatory colleagues as required.

Processes

• Follows Global Regulatory policies and procedures.
• Ensures that new processes are developed and implemented in order to leverage the global infrastructure and maximise efficiency, ensures that new processes are aligned with global policies, but also meet regional regulations and needs.
• Responsible for the Notification of Regulatory activities and RIM system entry/data accuracy for allocated projects.
• Responsible for ensuring forecasts are developed and actuals managed in line with regional requirements and communicating these to Area TA Head, GRL and R&D finance for assigned projects.

Qualifications & experience:

• Graduate in Life Sciences in a relevant area.
• Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within Area.
• Pharmaceutical industry experience in European Regulatory strategy development and regulatory procedures, EU centralised procedure essential. Experience of EU strategy for development assets e.g. scientific advice, paediatric investigation plans preferred.
• Experience working effectively across cultures and in complex matrixed environment.
• Excellent organizational skills and solution driven leadership style.

Essential Skills and Abilities

• 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 complex matrix environment.
• Good interpersonal and negotiation skills and the ability to influence others.
• Travel approximately 10%.

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.