Senior Director, Regulatory Affairs CMC

Regulatory Pleasanton, CA


The primary role of this position is to lead Regulatory Chemistry, Manufacturing & Controls (CMC) strategy of the company portfolio through interaction with multiple functions to facilitate the development of innovative therapeutics from early phase clinical trials through to marketing applications globally. 
Specific responsibilities include:
  • Participation in or lead cross-functional sub teams, development of regulatory CMC strategies, and lead RA CMC related activities
  • Preparation, coordination, review, and maintenance of high-quality regulatory dossiers that support product development strategy and meet current regional requirements
  • Lead the preparation of CMC-related interactions with regulatory health authorities
  • Lead and participate in health authority interactions such as formal meetings
  • Guide and support cross-functional teams in authoring and review of RA CMC related documents
  • Assessment of change controls and identification of supporting documents to support CMC changes
  • Proactively plan and submit CMC submissions to align with overall business objectives and to ensure supply continuity
  • Identification and implementation of process improvements which have an impact on Regulatory Affairs and/or other departments
  • Staying current with the changing regulatory requirements as they pertain to Gritstone’s products
  • Preparation and or maintenance of regulatory CMC related tracking systems for change controls, agency communications and commitments
  • Establish RA CMC related templates and other infrastructure as needed to support the progress of product related activities
  • Manage a direct report(s), serve as a mentor
Minimum Education/Experience
  • BS/MS degree (or equivalent) in life sciences, advanced degree preferred
  • 12+ years of experience in CMC or a related function within a biotechnology company (at least 8 years directly in the regulatory CMC function)
  • Direct experience managing regulatory CMC aspects of investigational biologic products essential, including strong knowledge of analytical characterization and release tests; process scale-up, transfer, and validation; GMP manufacturing facility and equipment
  • Demonstrate leadership, strategic agility, strong critical and logical thinking with ability to analyze and propose innovative solutions to problems
  • Strong sense of accountability, sound judgement, and attention to detail
  • Experience with preparing, IMPDs and INDs is required, experience with BLA, NDA and/or MAA submission(s) is preferred
  • Experience leading health authority interactions
  • Experience with Biologics is required; experience with Cell and  Gene Therapy products and Vaccines is strongly preferred
  • Experience with CBER-regulated products is required
  • Strong knowledge of applicable ICH, FDA, EMA and other relevant guidance documents
  • Team player and willingness to roll up the sleeves to achieve department objectives
  • Demonstrated ability to work well within a matrix structure in a complex environment.
  • Support the development of other team members and provide guidance on day-to-day activities as needed
  • Exercise good judgment in elevating and communicating actual or potential issues to line management and present solutions to those issues where applicable
Other Qualifications
  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with all levels of management and external partners
  • Creativity and critical thinking, ability to work with complex and innovative therapeutic modalities that lack regulatory precedent
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment; able to react nimbly to changes in timelines and strategy
  • Strong knowledge of cGMP for biologic products and manufacturing facilities; understanding of the biopharmaceutical development lifecycle
  • Self-motivated, self-disciplined, and able to function independently as well as part of a team
  • Experienced in participating in Health authority inspections
  • Excellent computer proficiency (MS Word, Excel, PowerPoint, Adobe Acrobat, and document management systems)
  • People management experience: coaching and developing individual contributors, ability to communicate effectively and leading people through organizational changes

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

The well-being and safety of our employees is our top priority. Gritstone requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (fully remote or site-based). Fully vaccinated is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.

Gritstone bio anticipates that the annual base salary for the Senior Director, Regulatory Affairs - CMC level position could range between $218,000 - $306,000. Compensation will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal position salary ranges, and market data. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Gritstone is a multistate employer and the salary offered will be market competitive. At Gritstone, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.

Gritstone’s benefit package includes medical, dental, vision, life insurance, and paid parental leave. Employees are also eligible to enroll in the 401k plan, which includes a 4% company match with immediate vesting. Employees are eligible to enroll in benefits effective the first day of employment and the competitive Paid Time Off (PTO) begins accruing on the first day as well. The job offer also includes an equity grant and eligibility for annual refresh grants based on performance. Gritstone employees also benefit from an Employee Stock Purchase Plan (ESPP) and thirteen (13) designated paid holidays as well as two (2) personal days.

Gritstone bio is an Equal Opportunity employer, as such, recruiting is conducted in a fair and non-discriminatory manner without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.