Associate-Director, Clinical Regulatory Affairs

Associate-Director, Clinical Regulatory Affairs

The Associate Director acts as the initial regulatory resource for clinical development activities on assigned projects, providing functional area leadership to the team and managing the project activities of other regulatory staff assigned to projects under their authority.

Job Responsibilities

· Responsible for coordinating the drafting, editing and preparation of regulatory submissions, (e.g., INDs, NDAs, annual reports, IND amendments, NDA supplements, routine correspondence).

· May direct interactions with drug regulatory agencies (US and non-US) on defined matters for assigned projects.

· Serves as the primary Regulatory Affairs representative to assigned clinical development teams(s) and interacts with other departments and with personnel from corporate partners.

· Responsible for organizing regulatory submission teams and coordinating the editing and preparation of clinical module or clinical content of regulatory submissions, (e.g., INDs, NDAs, annual reports, IND amendments, NDA supplements, routine correspondence).

· Coordinates preparation of clinical information and related activities for meetings with drug regulatory agencies.

· May be responsible for interactions on defined matters with drug regulatory agencies for assigned projects including the conduct of meetings and preparation of accurate meeting minutes.

· Participates in development of overall project goals and in particular those that pertain to clinical regulatory affairs.

· Participates in regulatory strategy and position papers for clinical development candidates, submissions, drug regulatory agency meetings and special regulatory issues.

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

· Participates in development of departmental methods and procedures.

· Manage the activities of other regulatory staff assigned to their projects.

 

Required Skills:

· Self-motivated and highly flexible individual who is able to manage multiple tasks and priorities within a fast-paced environment.

· Project management skills and experience.

· Editorial skills and ability; experience developing and managing technical processes and procedures.

· Excellent oral and excellent written communication skills

· Detailed knowledge of current FDA regulations and guidelines

· Must be able to effectively interact with internal and external customers to obtain accurate information and be a team player.

· Must possess the ability to manage multiple projects with competing deadlines