Associate Director/Director, Regulatory Affairs - Oncology

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Job description

Title: Associate Director / Director, Regulatory Affairs - Oncology
Reports To: Vice President, Regulatory Affairs - Oncology
Location: Redwood City, CA
Classification: Exempt

Overview:

This position is responsible for delivering on oncology clinical regulatory and commercial regulatory requirements of company biologics, and for managing regulatory activities that support the department. Responsible to manage and support clinical regulatory development activities and submissions for oncology products, participate on various product development teams, sub-teams, and submission teams; manage regulatory filings, follow review policies, review commercial regulatory materials (promotional and training materials). The incumbent will participate in management of regulatory intelligence for the group. Responsible for helping to develop strategies/timelines, conduct meetings, and may act as liaison with the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP). Works collaboratively with other team members and subject matter experts in Clinical Development, Medical Affairs, Commercial, Legal, Manufacturing, and Quality.

Essential Duties & Responsibilities:

Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:

• In support of clinical and commercial oncology products, implement regulatory strategies and plans
• Collaborative regulatory lead for oncology project teams, sub-teams and submission teams, effectively contributing to regulatory submissions (eg (pre)-IND, Protocols, Investigator Brochures, (pre)-BLA, Type C, Annual Reports, Post-Approval Supplements, Change Control, Pharmacovigilance) and business deliverables
• Work effectively with Commercial Team on post-approval supplements, line extensions, change control and necessary regulatory filings to support commercial products and post-marketing commitments for both the US and EU
• Ensure submissions to regulatory health authorities are complete, well-organized, of high quality, and compliant, working in concert with subject matter experts, external vendors and with Regulatory Operations
• Perform and manage effective and timely regulatory intelligence and research, in support of regulatory affairs and oncology clinical development
• Manage the regulatory aspects of promotional materials (press releases, website, social medial review, etc), as well as sales training materials
• Ensure quality submissions, including proofreading documents and working closely with Regulatory Operations to publish final regulatory OPDP submissions
• Keep current on the FDA OPDP environment and competitive products; communicate such environment to the teams
• Monitor current and evolving regulatory guidance, provide risk assessments and recommendations for various regulatory scenarios
• Support post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials, based on domestic and international regulatory requirements
• Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact the Company's promotion of products and operations - Advise personnel in other departments regarding their applicability and impact
• Interface with other team leaders to ensure coordination and implementation of consistent standards and processes
• Update and provide appropriate promotional compliance and regulatory training and education to contracted staff (eg contracted physicians, speaking on behalf of company)
• Provide appropriate promotional compliance and regulatory training and guidance to sales reps and medical science liaisons regarding their respective roles and responsibilities

Requirements:

• 7 - 10 years of experience in biopharmaceutical industry or equivalent, with a minimum of 4 years in Regulatory Affairs
• Bachelors degree; advanced degree preferred
• Must be able to search, retrieve, interpret and apply government regulations
• Experience in establishing and managing regulatory intelligence through search evaluation and distillation of regulatory and oncology clinical data sources
• Experience and a thorough understanding of the preparation of promotional material and the translation of regulatory requirements into practical plans
• Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills
• Exceptional cross-functional team leadership skills, and ability to work in close collaboration with other
• Strong organizational and planning skills for self and others, and strong attention to detail
• Accountable for results and goal attainment
• Experience with electronic submissions requirements and the review of promotional materials prepared in support of regulatory filings
• Ability to work independently with limited supervision, adapt to change and manage multiple tasks
• Ability to problem-solve and make decisions on complex issues, often in a cross-functional team setting
• Technical knowledge of US regulations and ICH and GXP Guidelines
• Strong computer skills in Office, Access and Adobe Acrobat and working knowledge of electronic publishing/file management
• This position will require periodic travel (up to 10%) in the US

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.