Labcorp Drug Development is seeking candidates for a Manager, Regulatory Submissions. The Manager, Regulatory Submissions will be remotely located anywhere within the United States.
The Manager, Regulatory Submissions will be responsible for ensuring the timely submissions of appropriate documentation to Regulatory Authorities globally prior to the performance of clinical trials, and again prior to marketing of a new pharmaceutical product, as well as any associated maintenance activities.
This position is responsible for the management of a team of regulatory professionals and/orresponsible for timely preparation/coordination of regulatory submissions for a particular project and must work to high standards (governmental, Sponsor, Labcorp Drug Development 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 Labcorp Drug Development project team.
This position will act as liaison between the client and Regulatory Authorities. The positionrequires proactive interactions with all levels within Labcorp Drug Development and clients and will also be responsible for assisting other Labcorp Drug Development staff in business development activities related to regulatory submissions.
This position will provide the highest quality advice on regulatory issues to members of Labcorp Drug Development 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 Labcorp Drug Developmentbusiness operations.
- Prepare/review study documentation such as the core EudraCT Form (Annex I, II & III) andcover letter.
- Coordinate the preparation of high quality submissions (or parts of submissions) to regulatoryagencies 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 byRegulatory Authorities.
- Manage projects to the contracted estimate to ensure closing projects within budget. Regularlymonitor 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 participateindependently 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 inthe 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 submissionprojects and for subsequent adherence to the plans.
- Participate in training of Labcorp Drug Development personnel.
- Assist in the development and updating of Regulatory Submission SOPs.
- Interact with the Publishing group, Copy Center or equivalent as necessary for the productionof 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 andregulations as they pertain to investigational drug regulations in particular.
- Minimum of 5 years experience in the Pharmaceutical industry in Regulatory Affairs or DrugDevelopment.
- Excellent communication, organization and planning skills with an attention to detail.
- Direct supervisory and project management skills and ability to work independently.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us.