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)646-367-2908 or n.walker@proclinical.com.
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.