Project Manager, Regulatory Affairs
Project Manager, Regulatory Affairs
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
MAIN PURPOSE OF JOB
With supervision and guidance from line manager;
- Acts as the primary Regulatory contact for identified portfolio.
- Supports lifecycle management of applicable products and management of paediatric investigation plans and clinical trial activities with the Medicines and Healthcare Products Agency (MHRA).
- Acts as the Regulatory Lead with the Affiliate Asset and Brand Teams to provide regulatory information on assigned products and develop robust regulatory strategies and timelines for those products throughout their lifecycle.
- Develop and maintain relationships with cross functional partners as well as the Area Regulatory team to advocate the UK strategy objectives and timelines through the Area Regulatory Project Team.
- Serves as Health Authority liaison and interface for Health Authority for meetings to obtain optimal outcomes for patients and AbbVies portfolio.
- Supports the business in planning for and execution of product launches acquisitions and divestitures as required.
- Regulatory intelligence and external landscape monitoring provide regulatory impact assessment and establish best practice.
MAIN ACCOUNTABILITIES
Regulatory Strategy and Tactical Implementation
- Acts as conduit between the Area and Brand teams as required to ensure local strategy is considered and that the key regulatory messaging is understood.
- Ensures submission and content of new Marketing Authorisations variations and other regulatory submissions paediatric investigation plans and clinical trials are made in accordance with appropriate timings and requirements and maintain appropriate tracking of the process as applicable.
- Reviews regulatory submissions for UKRA team for assigned areas of responsibility corrects where necessary and provides feedback as required.
- Monitors regulatory intelligence and external landscape for identified portfolio/area of responsibility and cascades information as appropriate.
Regulatory Compliance
- Ensures adherence to AbbVies policies and procedures to meet statutory quality and business requirements acts as a regulatory contact for audits and inspections in UK as appropriate and has oversight of divisional policies and procedures.
- Ensures promotional non-promotional and training materials are examined in compliance with local regulations and internal policies and procedure (where applicable).
Liaison with Internal Stakeholders
- Act 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 deputy to the SeniorRegulatory Affairs Project Manager or Manager on committees/initiatives as required.
Leadership for UK Regulatory Therapeutic portfolio
- Provide strong leadership for identified portfolio support:
- Successful implementation of regulatory product strategies.
- Develop and maintain strong working relationships with MHRA. Process Improvement internal compliance and team consistency.
GENERAL ACCOUNTABILITIES
To comply with the companys policies and procedures to meet statutory quality and business requirements within the overall strategy and objectives of AbbVie Ltd.
Responsible for the health safety and environmental performance of themselves and others through compliance within EHS programs regulations and standards. Subject to the policy and procedures outlined in the EHS Handbook.
Qualifications :
- Regulatory professional with relevant experience in the pharmaceutical industry with a clear understanding of the UK regulatory submissions process
- Sense of personal responsibility accountability and with a positive can-do attitude
- Strong negotiation influencing and presentation skills
- Consultative and collaborative interpersonal style
- Excellent written verbal and interpersonal skills (in English)
- Ability to work with minimal supervision multitask prioritise and manage multiple projects and deadlines
- Ability to work effectively and collaboratively across cultures and cross-functionally
- Ability to identify compliance risks and escalate when necessary
- Life Sciences Degree in relevant subject area is preferred
- 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:
No
Employment Type :
Full-time
Employment Type
Full-time
