Manager or Senior Manager, Regulatory Affairs

Job Description
Description:


The Manager/Senior Manager, Regulatory Affairs is a mid-level position in the Regulatory Affairs department. The level assigned will be commensurate of the experience of the candidate.

The position will report directly to the Associate Director, Regulatory Affairs. The person filling this position will be primarily responsible for activities pertaining to submissions to and communications with Health Authorities. The Manager/Senior Manager has primary responsibility for interactions and negotiations with domestic and foreign regulatory agencies on assigned projects. This includes management of the preparation, review, compilation and submission of regulatory filings to FDA and other Health Authorities as necessary.

Job Requirements:

Has primary responsibility for coordinating the drafting, editing, and preparation of regulatory submissions (including routine correspondence, INDs, BLAs, NDAs, Annual
Reports, Amendments, Supplements, etc.). Manages internal and external activities to ensure the prompt provision of information necessary for such submissions.

Has primary responsibility for interactions and negotiations with domestic and foreign regulatory agencies on assigned projects.

Negotiates, interacts with, and supervises the activities of contract research organizations in the preparation of regulatory submissions or other actions, as necessary.

Serves as the primary Regulatory Affairs representative to assigned Project Team(s) and interacts with other departments, Health Authorities and personnel from corporate partners in order to achieve common goals.

Maintains working relationships with the Health Authorities and InterMune Project team Members.

Participates in the development, implementation and enforcement of regulatory policy.

Advises relevant corporate personnel regarding regulatory strategies, potential areas of concern and new governmental/regulatory developments. Assists in project planning and timeline development.

Determines methods and procedures in new assignments and will assist in the management of activities of Regulatory Affairs staff in the conduct of their duties.

Maintains a thorough working knowledge of the public resources of Health Authorities (regulations, guidelines, FOI resources, etc.).

Supports the Associate Director in ad-hoc assignments that may be related to other efforts within the Regulatory Affairs group.

Leads and participates in Departmental activities that support increased understanding of Regulatory Affairs and processes, such as the development of SOPs.

Qualifications:

BS/BA or higher in a scientific discipline.

Minimum of 4-6 years of experience in a regulatory affairs position in a company involved in the research, manufacture, testing or distribution of pharmaceutical products.

Effectively communicates (written and spoken); messages are clear and understood.

Understands current and possible future business trends and information.

Detailed knowledge and understanding of current GXPs. Knowledge of foreign regulations pertaining to the manufacture and distribution of biologics or drugs is helpful.

Experience in the preparation and submission of INDs, BLAs, NDAs, Annual Reports, Amendments, and Supplements.

Has a good understanding of all functional areas of the company (CMC, Preclinical, Project Management, Clinical, Finance, and Marketing) such that the individual can contribute to Team discussions surrounding issues in each respective area.

Basic understanding of Clinical Trials Directive and other ex-US regulations as well as the mechanisms for initiating and maintaining CTAs is desirable.

Company

InterMune

Job Code

State or Province

California

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