Regulatory Affairs Associate - United Kingdom
|Regulatory Affairs Associate|
|Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.|
|Purpose of the Job: |
The purpose of the Affiliate Regulatory Affairs Associate is to obtain licences for new products and maintain licences for existing products on advice of the regulatory affairs manager for the UK, Ireland, Cyprus and Malta.
Compilation and submission of clinical trial applications as required.
1. Perform local regulatory affairs activities on a day to day basis under supervision by:
• Obtaining and maintaining product licences for marketing affiliate by filing submissions to local regulatory agency, e.g. new licences, line extensions, variations (Chemistry, Manufacturing and Control (CM&C), clinical, labelling etc.) and renewals;
• Supporting responses and issue resolution with regulators.
• Providing regulatory input to and compiling local Clinical Trial Applications (CTAs), amendments, end of trial declarations, safety reports for submission to the local regulatory agency, review of clinical trial labeling, working closely with Medical and Clinical Operations;
• Using and updating corporate regulatory systems e.g. RAPT (Regulatory Activity Planning and Tracking), RRIC (Regulatory Requirements in Intercontinental Region) and the Clinical Trials Database as applicable;
• Ensure translation of the SPC and labelling for Malta, then coordinate the internal review and validation.
2. Contribute to the successful implementation of local commercial objectives by:
• Beginning to establish relationship with junior officials in the local regulatory agency (via direct interactions or industry associations);
• Building and maintaining relationships with Medical and Marketing in the affiliate to facilitate submissions, review of promotional materials and timely update of labelling materials (as appropriate). Gaining support for solutions to standard or small scale issues;
• Responding to queries on regulatory processes and regulatory status;
• Analysing possible solutions to solve a range of regulatory problems;
• Becoming knowledgeable on all aspects of regulatory affairs and aware of national legislation and guidance as well as some areas of the latest regional legislation and/or ICH guidance if applicable;
• Using appropriate SOPs as required by Global Regulatory Affairs policies (e.g. Regulatory Quality Systems), local regulations and acceptable Good Regulatory Practices.
|Minimum Requirements: |
• Relevant scientific degree or Bachelor's degree in physical or biological sciences required;
• Foundational knowledge and understanding of local and global regulatory procedures as well as European ones as applicable
• Good knowledge of written and spoken English;
• Good communication skills and ability to prioritise;
• Able to make decisions that impact own priorities and allocation of time to meet deadlines;
• Able to impact within local area.