Senior Manager, Regulatory Affairs

Hybrid in Maidenhead·Full-time·Added 1 month ago (last checked 8 Oct)

AbbVie

22 open roles

Apply

Overview

Job details

Full-time
Per the ad.
Hybrid
Office and home days — the ad has the split.

Requirements

Be near Maidenhead for hybrid days
No relocation package mentioned.
Have senior-level experience
Senior-level role.

Skills

The role

Located in Maidenhead (3 days per week Tuesday, Wednesday, Thursday)
Aligned with Neuroscience business unit
Excellent benefits and opportunities to progress

What you'll do

Acts as the primary Regulatory contact for identified therapeutic area of responsibility.
Provides line management responsibility for a small team within UK Regulatory Affairs, including recruitment, goal setting, performance appraisal and talent development.
Oversees all regulatory activities within therapeutic area of responsibility, including maintaining licensing whilst contributing to the Brand Team priorities.
Uses experience and knowledge of the regulatory landscape to guide team to develop robust regulatory strategies and timely submissions to the Medicines and Healthcare Products Agency (MHRA), ensuring the fastest approvals, implementations and product launches.
Develops and maintains relationships with Area & Affiliate members of GRS Europe and cross functional partners share knowledge, increase regulatory awareness and build networks.
Engages externally with the Health Authority on regulatory submissions and/or other pharmaceutical industry trade associations, as required.
Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.
Provides clear guidance and recommendations on UK regulatory strategies and tactical plans throughout a product lifecycle including clinical trial submissions, management of variations, paediatric investigation plans, new marketing authorisation applications and liaison with local regulatory authorities.
Reviews regulatory submissions for UKRA team for assigned areas of responsibility, corrects where necessary and provides feedback.
Regulatory intelligence and external landscape monitoring,
- Interacts with Regulatory policy makers and professional associations (eg ABPI) to gather knowledge about trends, future changes and current landscape in accordance with the national and EU legislation and relevant Associations’ Codes and advocate for AbbVie’s interests.
Ensures compliance with AbbVie’s policies and procedures to meet statutory, quality and business requirements, acting as primary point of regulatory contact for audits and inspections in the UK as appropriate and supporting oversight of divisional policies and procedures.
Ensures compliance with UK legislation for Medicines, Medical Devices, clinical trials and paediatric investigation plans and has an awareness of the ABPI code.
Acts as Regulatory liaison with Area and local UK cross functional teams to ensure UK strategies align with global strategies, whilst maintaining compliance with local regulations.
- Understand and articulate the regulatory perspective across the business, translating key regulatory decisions in terms of impact on products in the UK.
Acts as lead Regulatory representative on Affiliate committees/initiatives (as required).
Acts as deputy to the UK Regulatory Affairs Managers and/or Director (as required).

Qualifications

Experienced Regulatory professional in the pharmaceutical industry with a clear understanding of the UK regulatory and submissions process
Experience as a line manager with highly developed people skills
Sense of personal responsibility and accountability, with a positive, can-do attitude
Ability to multitask, prioritise, and manage multiple projects and deadlines
Ability to work effectively and collaboratively across cultures and cross-functionally
Strong diplomacy, influencing, presentation skills
Consultative and collaborative interpersonal style
Excellent written, verbal and interpersonal skills (in English)
Ability to identify compliance risks and escalate when necessary
Life Sciences Degree in relevant subject area
Computer literate

About AbbVie

Industry: Pharma
Founded: 2014
Employees: 40,000–50,000
Headquarters: North Chicago, USA
Website: abbvie.es

In their own words

About the company & team

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Provides strong leadership and direction to the UK Regulatory Therapeutic Regulatory team to support:
- Successful implementation of regulatory product strategies
- Develops and maintains strong working relationships with MHRA and local pharmaceutical company trade associations
- Process improvements, internal compliance and team consistency
- Individual professional development, improved capability and upskilling within team
- Supports recruitment activities (as required) and retain high calibre regulatory affairs professionals

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

All open roles at AbbVie