Director/Senior Director, Regulatory Affairs – Oncology

Location
Redwood City, California
Posted
Oct 07, 2021
Ref
3083901
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Title:                                     Director / Senior Director, Regulatory Affairs – Oncology
Reports To:                        
Vice President, Regulatory Affairs - Oncology
Location
:                             Redwood City, California
Classification:                   Exempt 

 

Overview:

This position will be responsible for providing global regulatory leadership in support of the development, registration, and life-cycle management of Coherus’ oncology products. He/she will ensure effective achievement of regulatory/business objectives across teams, within the department, and at the corporate level. As directed by the Vice President, the incumbent may assist in organization and management of staff in the group, including coaching, career development, and overseeing the work. The Director / Senior Director will help define, establish and deliver regulatory requirements of oncology company product(s) in development, for regulatory filings from IND to BLA and beyond, including meetings, Investigator Brochures, Annual Reports, Post-Approval Supplements, Pharmacovigilance and regulatory promotions review. Works collaboratively with other team members and subject matter experts in Clinical Development, Commercial, Legal, Manufacturing, Quality and Clinical Operations.

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:

  • Develop and implement competitive and effective global regulatory strategies for various oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
  • Represent Regulatory Affairs, Oncology on various cross-functional teams and sub-teams to establish, advance and manage development and regulatory strategies for early through late stage development programs
  • Manage the evolution of oncology clinical development program strategies within changing regulatory environment and approval requirements
  • Ensure quality submissions, including proofreading documents and working closely with Regulatory Operations to publish the final regulatory OPDP submissions
  • Manage, oversee, and ensure submissions to regulatory health authorities are complete, well-organized, of high quality, and compliant, aligned with subject matter experts, working with external vendors and with Regulatory Operations – these will include a variety of non-clinical, CMC and clinical documents
  • Maintain and communicate effective and timely regulatory intelligence and research, in support of regulatory affairs and oncology clinical development – Monitor current and evolving regulatory guidance, provide risk assessments and recommendations for various regulatory scenarios
  • Organize, facilitate and prepare for Health Authority meetings, meeting questions and requisite briefing documents
  • As directed, will assist in organizing and managing staff in the group, including coaching, career development, and overseeing the work
  • Effective team member on functional area and project team meetings, including nonclinical, clinical, and regulatory sub-teams as required
  • Interface with other team leaders to ensure coordination and implementation of consistent standards and processes

Requirements:

  • 10 - 12 years of experience in biopharmaceutical industry or equivalent, with a minimum of 8 years in Regulatory Affairs
  • Bachelors degree; advanced degree preferred
  • Proven understanding of complex development strategies in oncology
  • As a member of interdisciplinary teams, ability to successfully organize and manage multiple project deliverables, with ability to function independently in management of critical biopharmaceutical programs
  • Experience preparing, managing and submitting major regulatory submissions through all phases of clinical development
  • Must be able to interpret and apply government regulations
  • Experienced with searching and evaluating regulatory intelligence and pharmaceutical registration databases in support oncology product development and regulatory strategy
  • Superlative 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 others
  • Strong organizational and planning skills, as well as strong attention to detail
  • Accountable for results and goal attainment
  • Experience with electronic submissions requirements
  • 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
  • Prior experience in managing direct reports, including coaching and career development may be a plus
  • Technical knowledge of US regulations and ICH and GXP Guidelines
  • Strong computer skills in Word, Access and Adobe Acrobat and working knowledge of electronic publishing/file management
  • This position may 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.