Senior Manager Regulatory Affairs - Palo Alto, United States - Proclinical Staffing

Description

Senior Manager Regulatory Affairs - Remote - Permanent

Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candidates.

Primary Responsibilities:

The successful candidate will be responsible for supporting regulatory strategy, systems, processes, submissions, and health authority interactions. This role requires close collaboration with cross-functional team members within the company.

Skills & Requirements:

• In-depth knowledge and high level of technical competence of regulatory systems (e.g., Veeva RIM and StartingPoint templates).
• Strong communication and collaboration skills.
• Experience in regulatory affairs within the pharmaceutical/biotechnology industry.

The Senior Manager will:

• Support the implementation of the regional regulatory strategy and regulatory submission plans in line with business objectives.
• Facilitate tactical implementation at the regional level and contribute to effective communications with regional and global teams on product activities and issues.
• Participate in the preparation for meetings with regional regulatory agencies.
• Support communications with FDA in support of submissions.
• Prepare, review, and provide input on documents for submission to regional regulatory agencies.
• Collaborate with regulatory team members and functional subject matter experts to build and maintain the content plan for INDs, NDAs, etc. to ensure timely delivery of submission components.
• Maintain current IND, ODD, and NDA submissions by ensuring timely and appropriate submission of required information within eCTD sequence as well as maintaining logs.
• Contribute to the management of product lifecycle submissions (e.g., DSURs, IBs).

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) or .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.