Manager Regulatory Operations
Proclinical is currently recruiting for a Manager of Regulatory Operations for a biosimilar company located in San Francisco, CA. Successful candidate will be responsible for managing all publishing activities and submissions to health authorities.
- Provide operational oversight and support for the planning, preparation, tracking, publishing, QC, validation and timely submission of all eCTD applications and updates to global health authorities (e.g. IND, NDA, BLA, MAA, etc.).
- Manage communications and activities with third-party publishers.
- Manage and index archives of regulatory submissions.
- Lead the development and implementation of standards for publishing, archiving, metrics and submission process to global health authorities.
- Monitor and assess business trends, pending regulations or guidance documents and emerging technologies for potential regulatory operations impact, develop action plans, countries requirements guide, and business tools accordingly.
- Support budgeting and forecasting activities, including managing expenditures activities related to approved vendor contracts.
- Support and facilitate a solid team effort in meeting company goals.
Skills and Requirements:
- BS, or advanced degree, in life/physical sciences with three to five years regulatory affairs experience within the pharmaceutical or biotechnology industry.
- Regulatory submissions experience, ideally in all phases of product development, pre- and post-marketing. Specific experience with clinical, preclinical, CMC, and labeling submissions would be a plus. Direct experience interacting with FDA is desirable. The Manager must have the interest in, and ability to, expand his/her areas of regulatory expertise and the ability to apply scientific principles to complex regulatory issues.
- Writing skills that facilitate development of documentation and reports required for regulatory submissions and compliance. A proven ability to evaluate, analyze and interpret reports and other documents for regulatory submissions is essential.
- A strategic as well as an operational approach with the ability to "think outside the box" and to manage multiple tasks in a fast-paced environment.
- Excellent problem-solving ability and organizational skills, while maintaining attention to detail. A high energy level, a willingness and ability to work in a hands-on capacity, to adapt and respond to a rapidly changing environment, and to work effectively in a project team environment.
- Effective verbal and written communication skills, excellent interpersonal skills, and a team approach.
- The ability to establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.