Senior Regulatory Affairs Officer
6 months ago
**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. _**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. _
- _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._
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