Bracknell, United Kingdom
The Regulatory Officer is responsible for assisting the RA Department in the preparation, compilation, submission and maintenance of regulatory documentation required by international regulatory agencies for clinical trials and marketing applications. Correspondence with regulatory agencies and communication with Sponsors, vendors and contractors will also be the responsibility of the Manager.
The Regulatory Officer will work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Problem solving requires the exercise of judgment within generally defined practices and company policies in recommending the proper course of action. The employee will gather information, reports, and data and perform analysis to assist management in solving problems of major or critical nature and provide regulatory input to clinical and regulatory strategies, acting as a key liaison with Sponsoring companies.
- Advise Clinical and Project Management teams on local regulatory and ethical requirements;
- Provide high-level direction to regulatory strategy for drug development and input to clinical strategies and review clinical documentation for the planning of clinical development programmes;
- Prepare, compile and submit regulatory documentation to EU and CEE countries:
- Manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices);
- Ensure relevant documents in compliance with local regulatory/ethical requirements, including but not limited to CTAs, drug labels, subject information sheet and consent form, etc. are being provided appropriately;
- Review and approve technical, pre-clinical and clinical reports for regulatory submissions;
- Liaise with sponsors, regulatory and clinical consultants, and Regulatory Agencies where necessary.
- Compile dossiers for Marketing and Product Authorization, including variations and notifications on paper and electronic media as appropriate;
- Prepare IMPDs, compliance reviews of SmPCs and reviews of product labels and patient leaflets;
- Supervise and coordinate Regulatory Advisors in local Country offices;
- Drive interactions with regulatory authorities and Sponsors;
- Access regulatory agency websites and/or contact regulatory authority at regular intervals for updates on regulations, guidelines and procedures. Ensure these changes and updates are communicated and circulated as appropriate;
- Develop a Regulatory Affairs Department, as appropriate, based on the requirements of Pharm-Olam and the growth of business for the group.
- Report directly to the Director/VP Regulatory Affairs;
- Direct supervision of Pharm-Olam regulatory professionals worldwide as assigned;
- Collaborate with Clinical Operations, Medical Affairs and Medical Writing, Data Management and Biostatistics, Quality Assurance, Business Development and Marketing Executives and staff;
- Collaborate with Pharm-Olam Program and project teams;
- Collaborate with Clinical Trial Administrators, Support Services and Quality Assurance personnel;
- Collaborate with local office management and Information Technology;
- Liaise with national regulatory agencies and competent authorities;
- Liaise with Sponsor scientific, medical, and corporate staff;
- Liaise with sub-contractors.
- Four year college curriculum or BS/BA degree in a scientific discipline, especially a medical or biological science;
- Generally 3-5 years experience in regulatory affairs in the pharmaceutical or biotechnology industry;
- A thorough knowledge of European and CEE regulatory submission and reporting requirements and guidelines;
- Excellent understanding of the drug development process;
- Excellent oral and written communications skills;
- Attention to detail;
- Able to thrive in a stressful environment and ability to work with changing priorities;
- Able to perform well as a team member.