Associate Director/Director, Regulatory Operations
Title: Associate Director/Director, Regulatory Operations
Reports To: Director, Regulatory Affairs or above
Location: Redwood City, California
The Associate Director/Director of Regulatory Operations will be responsible for working hands on and managing a small Regulatory Operations team to complete the Regulatory Operations activities. In this fast-paced environment, he/she will have the opportunity to work in a hands-on capacity to work on projects from new product concepts through marketed products. He/she will be a creative and independent thinker while supporting and facilitating a solid team effort in meeting company goals.
Principal Responsibilities and Duties:
The Regulatory Operations Associate Director/Director and Regulatory Operations team is responsible for:
- Working closely with Regulatory Affairs, Program Management, and Product Development Teams to provide operational oversight and support for the planning, preparation, tracking, and timely submission of all eCTD applications and updates to global health authorities (e.g. IND, NDA, BLA, MAA, etc.).
- Managing all publishing activities including: ensuring documents are submission ready, preparation and transfer of final documents to a third-party publishing organization, troubleshooting and supporting the third-party publisher during submission preparation, managing and completing QC of output from third-party publisher, confirming submission to the health authority.
- Managing all communications, planning, and other activities with a third-party publishing organization.
- Tracking regulatory commitments and deliverables to health authorities.
- Managing all activities and communications with third-party technical writers.
- Providing input and guidance on current technical aspects of submission requirements such as CDISC nonclinical and clinical dataset requirements, etc.
- Leading the development and implementation of standard procedures for publishing, archiving, metrics, and submission process to global health authorities.
- Developing and maintaining templates and style guides for regulatory submissions.
- Maintaining an index and archive of all regulatory submissions and correspondence.
- Maintaining and improving our sharepoint site used for authoring of regulatory documents.
- Manages the evaluation and implementation of a regulatory management system.
- Monitors and assesses business trends, pending regulations or guidance documents and emerging technologies for potential regulatory operations impact, develop action plans, countries requirements guides, and business tools accordingly.
- Supports budgeting and forecasting activities, including managing expenditures activities related to approved vendor contracts.
Education/Experience/Skills: The ideal candidate will offer:
- A BS, or advanced degree, in life/physical sciences with 7+ years regulatory affairs or regulatory operations experience within the pharmaceutical or biotechnology industry.
- Regulatory submissions experience particularly with large applications such as NDA, BLA, MAA etc. Ideally experienced in all phases of product development, pre- and post-marketing.
- Experience managing a team.
- Experience implementing and maintaining document management systems.
- 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.
Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.