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THE POSITION

• We are looking for an experienced and enthusiastic Regulatory Affairs professional looking to take your next step in our UK & Ireland Regulatory Affairs department. You will take responsibility for supporting a range of licensed products throughout the product lifecycle as well as compounds in the pre-license phase inputting to and implementing local regulatory strategies in support of local business priorities.

Tasks & responsibilities

• Working in full compliance with company processes, provide full regulatory support for assigned licensed products in UK, Ireland and Malta across the full product lifecycle from pre-launch, launch, maintenance, through to discontinuation and divestment.

• Prepare and implement updates to SmPCs and prepare and review updates to packaging artwork.

• Working closely with colleagues in clinical operations provide full regulatory support for assigned clinical trials including new CTAs, amendments, safety updates and other updates as required.

• Develop, communicate and implement local regulatory strategies in line with business needs and priorities.

• Maintain global databases and other global and local trackers and in an accurate and timely manner. Contribute to local and global quality and process improvements and provide support to audits and inspections.

• Take responsibility for completion of assigned training and a maintain and up to date knowledge of regulatory requirements and apply these to assigned products and more broadly to new situations as required.

Requirements

• Degree in a suitable scientific discipline and demonstrable experience in a UK regulatory environment supporting products across the full lifecycle.

• Ideally experience developing local regulatory strategies for products coming up to first registration and during the full lifecycle, considering and reflecting the needs of the business.

• Ability to work independently and proactively managing a heavy and varied workload with possible conflicting and changing deadlines, able to respond quickly and positively to changes with a flexible can-do attitude. Able to seek out and apply knowledge to new situations aware of the business impact, whilst being able to identify when additional support or input is needed.

• A strong team player with good interpersonal skills, able to interact with and engage and influence a range of internal and external stakeholders.

• Excellent written communication with a strong attention to detail and a strong compliance mindset.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.