Regulatory Affairs Specialist

Job Description

MISSION:

TheRegulatory Affairs Specialist supports theregulatory vision andleadership of the Regulatory Team. They executethese responsibilities by utilizing experience, knowledge of regulatory landscape, passion and creativity to provide patient-centric and compliant regulatory expertise in line with AbbVie’s vision. They supportthe best interests of patients, the Affiliate and AbbViewithin the country with regard to interactions with the regulatory agency and other regulatory authorities. Within AbbVie theyrepresent thedepartment and affiliateto the wider organization throughout the product lifecycle. Theycontribute to thedepartment's overall success byexecutingtacticsand meeting objectivesin line with business goals and culture.

Overall responsibilities (together with manager’s 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 affiliate's strategy, objectives and timelines
• Works with the regulatory department and collaborates other stakeholders, as appropriate, to ensure compliance with the company’s 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 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