Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
MISSION:
The Regulatory Affairs Specialist supports the regulatory vision and leadership of the Regulatory Team. They execute these responsibilities by utilizing experience knowledge of regulatory landscape passion and creativity to provide patient-centric and compliant regulatory expertise in line with AbbVies vision. They support the best interests of patients the Affiliate and AbbVie within the country with regard to interactions with the regulatory agency and other regulatory authorities. Within AbbVie they represent the department and affiliate to the wider organization throughout the product lifecycle. They contribute to the departments overall success by executing tactics and meeting objectives in line with business goals and culture.
Overall responsibilities (together with managers oversight)
- Supports the business of the company including involvement in planning for product launches acquisitions and divestitures
- Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA
- Work with Area Regulatory team to help advocate for the affiliates strategy objectives and timelines
- Works with the regulatory department and collaborates other stakeholders as appropriate to ensure compliance with the companys policies and procedures to meet statutory quality and business requirements within the overall strategy and objectives of AbbVie
- Authors SOPs workflows and guides relevant to regulatory processes as required.
Main Accountabilities
- Gain regulatory authority approval for new clinical trials and amendments to such trials undertaken by AbbVie Ltd in the UK
- Gain marketing authorisations for new pharmaceutical products in the UK
- Maintain marketing authorisations as required.
- Liaise with European Regulatory Affairs and Corporate groups on regulatory issues.
- Liaise with external regulatory authorities as required.
- Draft of packaging texts SmPCs PILs and Prescribing Information.
- Submit and obtain approval for Paediatric Investigation Plans (PIP)
- Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
Qualifications :
Required Education / Knowledge / Experience
- Life Sciences Degree (e.g. Pharmacy) or equivalent experience preferred
- Experience of working in a regulatory environment
- Good communication skills both verbal and written
- The ability to thrive in a changing environment and to re-prioritise workload to meet business needs
- Good project management skills desirable
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
