This position is responsible for the management of a team of regulatory professionals and/or responsible for timely preparation/coordination of regulatory submissions for a particular project and must work to high standards (governmental, Sponsor, Covance and self) with minimal supervision. It is the responsibility of this position to ensure that documents are prepared to the required standards by maintaining awareness of current regulatory standards related to drug submissions and clinical research, and be responsible for providing regulatory consultancy advice to client companies and/or the Covance project team.
This position will act as liaison between the client and Regulatory Authorities. The position requires proactive interactions with all levels within Covance and clients and will also be responsible for assisting other Covance staff in business development activities related to regulatory submissions.
This position will provide the highest quality advice on regulatory issues to members of Covance project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to submissions. This position will evaluate the impact of clinical/regulatory changes on assigned projects as well as Covance business operations.
- Prepare/review study documentation such as the core EudraCT Form (Annex I, II & III) and cover letter.
- Coordinate the preparation of high quality submissions (or parts of submissions) to regulatory agencies for clinical trial and marketing approval within project timelines. Review of regulatory documentation prepared by other professional staff and responsible for the review and critical evaluation of scientific and regulatory documents intended for submission to Regulatory Authorities.
- Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.
- Manage projects to the contracted estimate to ensure closing projects within budget. Regularly monitor project tasks and ensure that all Out-of-Scope work is documented to ensure Change Orders are generated as appropriate.
- May represent Regulatory Submissions in new proposal opportunities.
- Participate in project development and regulatory strategy planning sessions. Will participate independently in client meetings and will proactively liaise with clients on regulatory submission issues.
- Liaise with Regulatory Authorities on behalf of clients.
- Responsible for workload forecasts (resource utilization) for assigned projects and assistance in the preparation of Time and Cost Estimates for Regulatory Submissions, projects.
- Provide timely status on assigned projects as required.
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests.
- Responsible for the preparation and maintenance of project plans for regulatory submission projects and for subsequent adherence to the plans.
- Participate in training of Covance personnel.
- Assist in the development and updating of Regulatory Submission SOPs.
- Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
- Work on special regulatory projects as assigned.
- Occasional travel may be required.
- Bachelor’s Degree in Life Sciences or equivalent, possibly with a higher qualification.
- Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations in particular.
- Minimum of 5 years experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development.
- Excellent communication, organization and planning skills with an attention to detail.
- Direct supervisory and project management skills and ability to work independently.