Vice President, Regulatory Affairs - Oncology
Title: Vice President, Regulatory Affairs - Oncology
Reports To: Executive Vice President, Regulatory Affairs
Location: Redwood City, CA
In partnership with the EVP, Regulatory Affairs, the Vice President, Regulatory Affairs acts as a regulatory lead by providing regulatory strategy and support to development teams and ensuring that regulatory documents are compiled and submitted to relevant US and ex-US regulatory authorities in a timely manner.
The Vice President will be responsible for the strategy and content of all regulatory submissions for the oncology franchise and will interface directly with regulatory bodies. The position will have staff management responsibilities. They will be accountable for tracking regulatory trends and requirements in the market and assessing the impact on the therapeutic area portfolio. The Vice President, Regulatory Affairs will identify and implement the most effective, compliant path to regulatory approval for the company’s products ensuring that the potential value of the products is maximized.
Specific responsibilities include:
- Develop regulatory strategies aimed at gaining the earliest possible regulatory approval in US, EU, Japan and ROW.
- Develop effective working relationships with Regulatory Agencies and participate in Agency negotiations.
- Day-to-day management of Regulatory team members, including external consultants.
- Participate in the development of innovative regulatory strategies for life cycle product management.
- Serve as a key member of the leadership team and contribute to the development of product and business strategies to maximize the value of the company’s portfolio.
- Works with EVP to develop and execute worldwide regulatory strategies for products in development.
- Represents Regulatory Affairs at project team meetings and coordinates workflow between departments as well as CROs.
- Acts as Project Team Lead for key programs at Coherus.
- Coordinates, writes, compiles, document packages for regulatory submissions from development, manufacturing, preclinical and clinical areas per regulations/guidelines and company SOPs to support regulatory applications including investigational and marketing applications (IND, CTA, CTX, BLA, NDA, NDS, and MAA).
- Reviews and approves investigator site regulatory documents (i.e. investigator documents, Informed Consents, IRB/EC documents) according to US FDA requirements and/or country requirements for initiation of clinical sites and drug shipments.
- Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline areas relevant to assigned projects.
- Participates in department initiatives to improve standards and systems internally and maintain relationships with other departments including consultants and vendors.
- PhD in Pharmacology, Toxicology, Molecular Biology, Analytical Biochemistry, Pharmaceutical Sciences, or other relevant discipline is required. Candidates with MD and PhD are encouraged to apply
- 12+ experience in the pharmaceutical industry or with USFDA with 10+ years in Regulatory Affairs.
- Experience working on development, approval and evaluation of Oncology programs.
- Expert knowledge of US and international laws and regulations pertaining to drug development, commercialization, as well as GMP regulations.
- In-depth regulatory and development experience with investigational drugs in late stage development and with marketed products.
- Successful track record of leading IND/IMPD as well as BLA and MAA submissions for novel products and biologics/biosimilars.
- Experience working in partnership with FDA and other regulatory agencies.
- Collaborative style with the vision to help shape the regulatory pathways for Coherus products.
- Adept at cross-functional team collaboration and cross-functional team management.
- Strong leader with proven ability to lead multinational teams.
- Demonstrated ability to work in a small company environment where there is a need to play a both strategic and hands on role.
- Ability to manage multiple and varied tasks in a fast-moving environment, with excellent project management skills.
- Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, and working collaboratively with pharmaceutical partners are required.
- Must be flexible and willing to learn new areas of product development.
- Must be highly collaborative, with outstanding written, organization and communication skills.
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.