Project Manager, Regulatory Affairs

Maidenhead - UK

Monthly Salary: Not Disclosed

Posted on: 23-10-2025

Vacancies: 1 Vacancy

Job Summary

Job Overview

Implement regulatory strategies & deliverables for a portfolio of products early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) including EU and non-EU countries such as CEE countries Israel Turkey Switzerland and the UK. Include fair representation of the interest of EU countries into Global Regulatory Product Teams in alignment with the overarching global regulatory strategy and region specific requirements.
Responsible for assigned product maintenance and lifecycle management submissions in line with legal/regulatory requirements and regional business needs.
Contribute as required in the development of regional processes to maximize operational efficiency of regulatory activities within the region.
Develops and maintains knowledge of regulatory procedures and environment within the region.
Primary RA interface with Commercial Area Brand Team and in collaboration with the RA personnel in the affiliates.

Key Responsibilities

Implement regulatory strategies & deliverables including effective planning tracking archiving of activities especially submissions for early/late development and marketed products
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.
Supporting the drug development strategy defining options for including supporting Scientific Advice/PIP/IMPD creating briefing packages and co-ordinating and leading agency meetings logistics
Primary RA interface with Commercial Area Brand Team. Represent RA on Area Brand Teams
Provide strategic input for registration ensure the business needs are met by anticipating and mitigating regulatory risks
Primary interface to and from the RA personnel in the affiliates and provides product updates in Area Regulatory Product Teams (ARPTs)
Primary interface with local health authorities (via RA personnel in the affiliates where appropriate)
Interface with EMA for products within the Therapeutic Area on behalf of the Product Lead when required.
Provide leadership and support to RA personnel in the affiliates through ongoing communication. Assess scientific data provided by specialist units for registration purposes against ERA regulatory requirements identifying gaps and developing mitigation strategies. Ensure effective presentation of data complete and timely responses (including CTAs)
Provide Europe Area input on local implications through participation in Teams as needed (e.g. submission teams labelling working group including development of labelling negotiations).
Ensure regulatory compliance within ERA for the assigned compounds/products. Implement remediation plan to address identified gaps if any.
Support development and implementation of new processes and ensure that these meet regional regulations and needs
Responsible for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects.

Qualifications :

Education and Experience

Graduate in pharmacy biology chemistry pharmacology or a related Life Sciences subject or related experience
Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
Prior relevant experience in pharmaceutical Regulatory Affairs
Prior experience with regulatory procedures (including CP/DCP/MRP) and contributes to the effective functioning of the ERA team.

Essential Skills and Abilities

Demonstrated planning and organisation skills.
Ability to prioritise and manage multiple projects.
Ability to work effectively and collaboratively across the organisation.
Understands business needs and impact of regulatory issues on these.
Good interpersonal and negotiation skills and the ability to influence others without formal authority.
Excellent communication skills both written and verbal (in English).
Positive can do attitude
Experienced in working effectively across cultures and in complex matrixed environment.
Sensitivity to ERA culture and ways of doing business is helpful.
Willingness to travel as necessary (5% at least).
Computer literate

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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Job OverviewImplement regulatory strategies & deliverables for a portfolio of products early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) including EU and non-EU countries such as CEE countries Israel Turkey Switzerland and the UK. Include fair representation of...

Job Overview

Implement regulatory strategies & deliverables for a portfolio of products early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) including EU and non-EU countries such as CEE countries Israel Turkey Switzerland and the UK. Include fair representation of the interest of EU countries into Global Regulatory Product Teams in alignment with the overarching global regulatory strategy and region specific requirements.
Responsible for assigned product maintenance and lifecycle management submissions in line with legal/regulatory requirements and regional business needs.
Contribute as required in the development of regional processes to maximize operational efficiency of regulatory activities within the region.
Develops and maintains knowledge of regulatory procedures and environment within the region.
Primary RA interface with Commercial Area Brand Team and in collaboration with the RA personnel in the affiliates.

Key Responsibilities

Implement regulatory strategies & deliverables including effective planning tracking archiving of activities especially submissions for early/late development and marketed products
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.
Supporting the drug development strategy defining options for including supporting Scientific Advice/PIP/IMPD creating briefing packages and co-ordinating and leading agency meetings logistics
Primary RA interface with Commercial Area Brand Team. Represent RA on Area Brand Teams
Provide strategic input for registration ensure the business needs are met by anticipating and mitigating regulatory risks
Primary interface to and from the RA personnel in the affiliates and provides product updates in Area Regulatory Product Teams (ARPTs)
Primary interface with local health authorities (via RA personnel in the affiliates where appropriate)
Interface with EMA for products within the Therapeutic Area on behalf of the Product Lead when required.
Provide leadership and support to RA personnel in the affiliates through ongoing communication. Assess scientific data provided by specialist units for registration purposes against ERA regulatory requirements identifying gaps and developing mitigation strategies. Ensure effective presentation of data complete and timely responses (including CTAs)
Provide Europe Area input on local implications through participation in Teams as needed (e.g. submission teams labelling working group including development of labelling negotiations).
Ensure regulatory compliance within ERA for the assigned compounds/products. Implement remediation plan to address identified gaps if any.
Support development and implementation of new processes and ensure that these meet regional regulations and needs
Responsible for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects.

Qualifications :

Education and Experience

Graduate in pharmacy biology chemistry pharmacology or a related Life Sciences subject or related experience
Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
Prior relevant experience in pharmaceutical Regulatory Affairs
Prior experience with regulatory procedures (including CP/DCP/MRP) and contributes to the effective functioning of the ERA team.

Essential Skills and Abilities

Demonstrated planning and organisation skills.
Ability to prioritise and manage multiple projects.
Ability to work effectively and collaboratively across the organisation.
Understands business needs and impact of regulatory issues on these.
Good interpersonal and negotiation skills and the ability to influence others without formal authority.
Excellent communication skills both written and verbal (in English).
Positive can do attitude
Experienced in working effectively across cultures and in complex matrixed environment.
Sensitivity to ERA culture and ways of doing business is helpful.
Willingness to travel as necessary (5% at least).
Computer literate

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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Key Skills

Proofreading
Adobe Acrobat
FDA Regulations
Manufacturing & Controls
Biotechnology
Clinical Trials
Research & Development
GLP
cGMP
Product Development
Chemistry
Writing Skills

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About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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