- 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
- 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
- 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
-
Director, Regulatory Affairs CMC
2 weeks ago
TAIHO ONCOLOGY INC Pleasanton, United StatesLooking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our "People first" approach means we also highly value our employees, who work relentlessly to ...
-
Director, CMC Regulatory Affairs
3 weeks ago
Bayside Solutions Fremont, United StatesDirector, CMC Regulatory Affairs · Direct Hire Full-Time Role · Salary Range: $208,000 - $235,000 per year · Location: Redwood City, CA - Hybrid Role · Job Summary: · The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections o ...
-
Director, CMC Regulatory Affairs
4 weeks ago
Bayside Solutions Santa Clara, United StatesDirector, CMC Regulatory Affairs · Direct Hire Full-Time Role · Salary Range: $208,000 - $235,000 per year · Location: Redwood City, CA - Hybrid Role · Job Summary: · The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections o ...
-
Head of CMC Regulatory Affairs
2 weeks ago
Gilead Sciences, Inc. Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...
-
Head of CMC Regulatory Affairs
2 weeks ago
Gilead Sciences San Mateo, United StatesFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working rele ...
-
Director, CMC Regulatory Affairs
2 weeks ago
Bayside Solutions Santa Clara, United StatesDirector, CMC Regulatory Affairs · Direct Hire Full-Time Role · Salary Range: $208,000 - $235,000 per year · Location: Redwood City, CA - Hybrid Role · Job Summary: · The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC secti ...
-
Regulatory Affairs CMC Associate
2 weeks ago
Fladger Assoc. Inc. San Mateo, United StatesJob Description · Job DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities: · Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY · Provide Regulatory CMC support for bio ...
-
Regulatory Affairs CMC Associate
3 weeks ago
Fladger Assoc. Inc. San Mateo, United StatesJob Description · Job Description · Foster City, CA · Contract Duration: 6-18 months · Rate: Negotiable · Responsibilities: · Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY · Provide Regulatory C ...
-
Head of CMC Regulatory Affairs
3 weeks ago
Gilead Sciences Foster City, United StatesHead of CMC Regulatory Affairs – Small Molecules page is loaded · Head of CMC Regulatory Affairs – Small Molecules · Bewerben · locations · United States - California - Foster City · time type · Full time · posted on · Vor 18 Tagen ausgeschrieben · job requisition id · ...
-
Sr Manager/AD Regulatory Affairs CMC
2 days ago
BioSpace, Inc. San Francisco, United StatesJob Details · Responsibilities and Duties: Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictions · Oversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory s ...
-
Sr Director, CMC Regulatory Affairs
2 weeks ago
Gilead Sciences Foster City, United StatesSr Director, CMC Regulatory Affairs –Small Molecules · Job Description · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that ...
-
Senior Director, CMC Regulatory Affairs
3 weeks ago
Allogene Therapeutics South San Francisco, United StatesJob Description · About Allogene: · Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led ...
-
Quantum Ventures Alamo, United StatesAllergopharma GmbH & Co. KG, located in Reinbek, is part of the Dermapharm AG corporate group and is an internationally operating pharmaceutical company specializing in the development, production, and distribution of products for the diagnosis and treatment of allergic diseases. ...
-
Associate Director, Regulatory Affairs Cmc
2 days ago
ALX Oncology Inc. South San Francisco, United StatesWe are looking for an** Associate Director/Director, Regulatory Affairs CMC **to join our team. · **Responsibilities**: · These include but are not limited to: · - Providing dynamic regulatory leadership to project teams and working collaboratively with cross-functional team memb ...
-
Senior Manager, Regulatory Affairs, CMC
1 week ago
BeiGene San Mateo, United States**General** **Description:** · BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and ...
-
Head of CMC Regulatory Affairs Small Molecules
1 month ago
Gilead Sciences, Inc. Foster City, United States Full timeHead of CMC Regulatory Affairs Small Molecules · United States - California - Foster City · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discover ...
-
Gilead Sciences San Mateo, United StatesEnsuring the projects they are responsible for have a cohesive regulatory strategy that is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. The role will report directly to Head of CMC Regulatory Affairs Small Molecul Regulatory Affairs, Director, R ...
-
Gilead Sciences, Inc. Foster City, United States Full timeSr Director, CMC Regulatory Affairs Small Molecules · United States - California - Foster City · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new dis ...
-
Gilead Sciences, Inc. Foster City, United States Full timeSr Director, CMC Regulatory Affairs Small Molecules · United States - California - Foster City · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new dis ...
-
Director, Regulatory Strategy
1 week ago
Exelixis Alameda, United States Full timeSUMMARY/JOB PURPOSE: · Manages all regulatory activities for new development programs, pre-IND through BLA/NDA and post-approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Provides expertise ...
Senior Director, Regulatory Affairs CMC - Pleasanton, United States - Gritstone bio
Description
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:
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.
