- Develop and lead CMC Regulatory strategies for a portfolio of programs in development, including AAV gene therapies and small molecule drugs.
- Proactively guide CMC team to design, develop, and implement submission documents and best practices for CTD quality modules to streamline preparation of CMC submission content.
- Participate on cross-functional CMC teams and provide regulatory CMC guidance for assigned products.
- Function as the Regulatory CMC lead on viral vector project and submission teams by applying advanced knowledge of regulations. Interpret technical regulatory guidelines to ensure that regulatory submissions are in compliance with applicable regulations.
- Strategize on deliverables to ensure Module 3 content associated with viral vector meets regulatory requirements and projected business timelines.
- Identify CMC risk areas and develop alternative courses of actions including anticipation of regulators responses through scenario planning and development of contingency plans.
- Align CMC regulatory strategy to overall regulatory business strategy (e.g. viral vector upcoming process, raw material, shelf-life and analytical changes).
- Responsible for assessment of all CMC related changes associated with viral vector and facilities/ equipment.
- Provide regulatory CMC expertise during due diligence and in support of new projects associated with viral vector.
- Responsible for submitting or ensuring submission of all regulatory documents that are required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories.
- Maintain an in-depth knowledge of ICH requirements, and an understanding of current global trends in CMC Regulatory Affairs.
- BS in a scientific discipline is required. MS or preferred
- Ten or more years of Regulatory CMC experience for biologic therapeutics.
- At least two or more years of Regulatory CMC experience with AAV Gene Therapy programs is required.
- Proven sound understanding of molecular biology and cell culture.
- Strong knowledge and understanding of US and ex-US regulations and ICH guidelines.
- Experience working directly with FDA/CBER, including meeting preparation and responding to inquiries. Experience working with Ex-US Health Authorities (EMA and MHRA) a plus.
- In-depth understanding of cGMP requirements of manufacturing facilities and equipment in support of clinical and commercial productions.
- Proven experience in supporting regulatory inspections.
- In-depth knowledge and experience in viral vector production, purification, characterization and analytics.
- In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
- A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
- Experience in authoring technical content of regulatory submissions and capable of leading a CMC sub-team in preparation of submissions.
- Experience and knowledge in the preparation of electronic submissions.
- Proven leadership to rapidly adapt strategy to unanticipated changes.
- Ability to work independently
- Excellent written and communication skills and attention to detail
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, quality, and supply chain
- Must be detail oriented and can deal with frequent changes in product activity
- Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.
-
Senior Director/Director
3 weeks ago
Kearns & West Inc San Francisco, CA, United StatesJob Description · Job Description · Kearns & West · Senior Director/Director · San Francisco, California · About the Job · THE ORGANIZATION · Kearns & West, Inc. is a stakeholder engagement, communications, and collaborative solutions firm. Our staff is passionate about en ...
-
Senior Director/Director
3 days ago
Kearns & West Inc San Francisco, United StatesJob Description · Job DescriptionKearns & West · Senior Director/Director · San Francisco, California · About the Job · THE ORGANIZATION · Kearns & West, Inc. is a stakeholder engagement, communications, and collaborative solutions firm. Our staff is passionate about engaging com ...
-
Senior Director
1 week ago
Hood & Strong San Francisco, United States3 weeks ago · Be among the first 25 applicants · This range is provided by Hood & Strong LLP. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Base pay range · $165,000.00/yr - $175,000.00/yr · Job Overview: · Hood & Strong ...
-
Senior Director
1 day ago
Altos Labs San Francisco, United StatesOur Mission · Our mission is to restore cell health and resilience through cell rejuvenation to reverse disease, injury, and the disabilities that can occur throughout life. · For more information, see our website at · Our Value · Our Single Altos Value: Everyone Owns Achieving ...
-
Senior Director
1 day ago
HI-Bio San Francisco, United StatesJOB TITLE: Director/Senior Director, Medical Affairs · DEPARTMENT: Clinical Development · LOCATION: South San Francisco, California · TYPE: Full-Time (Hybrid) · Is this your next job Read the full description below to find out, and do not hesitate to make an application. · A ...
-
Senior Director
1 week ago
Innovaccer San Francisco, United StatesAbout the Role · As a Senior Director of Product Marketing at Innovaccer, you will play an instrumental role in launching and promoting a suite of AI-enabled products that are transforming healthcare. Innovaccer is the trusted AI technology partner for leading healthcare organiz ...
-
Senior Director
2 weeks ago
Innovaccer Inc. San Francisco, CA, United StatesAs a Senior Director of Product Marketing at Innovaccer, you will play an instrumental role in launching and promoting a suite of AI-enabled products that are transforming healthcare. Innovaccer is the trusted AI technology partner for leading healthcare organizations, enabling c ...
-
Senior Director
2 weeks ago
Innovaccer Inc. San Francisco, CA, United StatesAbout the Role · As a Senior Director of Product Marketing at Innovaccer, you will play an instrumental role in launching and promoting a suite of AI-enabled products that are transforming healthcare. Innovaccer is the trusted AI technology partner for leading healthcare organiz ...
-
Senior Director
2 weeks ago
Alexandria Real Estate Equities, Inc San Francisco, CA, United StatesSenior Director - Property Management/Asset Services** · Job Function **Asset Services** · Employment Status **Regular, Full-Time, Exempt** · Alexandria Real Estate Equities, Inc. (NYSE: ARE), an S&P 500 company, is a best-in-class, mission-driven life science REIT making a posit ...
-
Senior Director
5 days ago
Adobe Systems Incorporated San Francisco, United StatesOur Company · Changing the world through digital experiences is what Adobe's all about. We give everyone-from emerging artists to global brands-everything they need to design and deliver exceptional digital experiences We're passionate about empowering people to create beautiful ...
-
Senior Director
2 weeks ago
Bristol-Myers Squibb San Francisco, CA, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
senior director
2 weeks ago
Third Rock Ventures San Francisco, CA, United StatesThe heart of insitro's strategy is the combination of novel, cutting edge methods in machine learning, biology at scale and small molecule discovery that address key bottlenecks in the drug development pipeline. To accomplish that, we are putting together an incredible team of di ...
-
Director/Senior Director of Pharmacometrics
3 weeks ago
EPM Scientific - Phaidon International San Francisco, CA, United StatesJoin a dynamic, fast-paced biotechnology company based in South San Francisco dedicated to advancing oncology therapies We are seeking a highly skilled and experienced Director/Senior Director of Pharmacometrics to contribute to the success of the company's drug development progr ...
-
Senior Director/Executive Director
1 week ago
Alexandria Real Estate San Francisco, United StatesThe Senior Director - Laboratory Operations & Environmental, Health & Safety is responsible for developing and managing Environmental, Health & Safety (EH&S) programs to meet the company's strategic and tactical needs in coordination with members of the Asset Services and Facilit ...
-
Senior Director/Executive Director
2 weeks ago
Alexandria Real Estate Equities, Inc San Francisco, CA, United StatesSenior Director/Executive Director Laboratory Operations & Environmental, Health & Safety** · Job Function **Asset Services** · Employment Status **Regular, Full-Time, Exempt** · Alexandria Real Estate Equities, Inc. (NYSE: ARE), an S&P 500 company, is a best-in-class, mission-dr ...
-
Senior Director
3 days ago
Pattern Energy San Francisco, United StatesOverview · Pattern Energy is a leading renewable energy company that develops, constructs, owns, and operates high-quality wind and solar generation, transmission, and energy storage facilities. Our mission is to transition the world to renewable energy through the sustainable d ...
-
Director/Senior Director, Platforms
3 weeks ago
Socotra, Inc. San Francisco, CA, United StatesAt Lyft, community is what we are and it's what we do. To create the best ride for all, we start in our own community by creating an open, inclusive, and diverse organization where all team members are recognized for what they bring. · The focus for the Community Safety team is ...
-
Senior Director/Executive Director
3 weeks ago
Alexandria Real Estate San Francisco, CA, United StatesThe Senior Director - Laboratory Operations & Environmental, Health & Safety is responsible for developing and managing Environmental, Health & Safety (EH&S) programs to meet the company's strategic and tactical needs in coordination with members of the Asset Services and Facilit ...
-
Director/Senior Director, Platforms
3 weeks ago
primer San Francisco, CA, United StatesAs a Senior Director, Product , you'll guide products from ideation to launch for some of the world's largest enterprises. You'll be responsible for understanding customer needs through data, conversations, and any other means necessary. You'll work closely with Engineering, Desi ...
-
Senior Director/Executive Director
3 weeks ago
Knewin San Francisco, CA, United StatesThe Senior Director – Laboratory Operations & Environmental, Health & Safety is responsible for developing and managing Environmental, Health & Safety (EH&S) programs to meet the company's strategic and tactical needs in coordination with members of the Asset Services and Facilit ...
Regulatory CMC Executive Director or Senior Director - San Francisco, CA, United States - Dennis Partners
Description
This clinical-stage biotechnology company is developing potentially curative therapies for heart disease. They are seeking a Regulatory CMC Executive Director or Senior Director to lead CMC Regulatory strategies and execution for their portfolio of programs. Reporting into the SVP of Regulatory, you will lead CMC submissions and work directly with health authorities. This company offers a science-driven, patient-focused culture and excellent employee benefits. With multiple programs in clinical trials, now is an exciting time to join this growing company
Responsibilities:
Background and Qualifications:
Interpersonal and Soft Skills:
This is an onsite position in the San Francisco Bay Area and this individual must be onsite 2-3 days a week.
The budgeted salary range for this position is US$250,000 to $320,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate's skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of remuneration.
#J-18808-Ljbffr