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Sr. Manager, Regulatory CMC
6 days ago
Neurocrine Biosciences San Diego, United StatesWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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Assoc. Regulatory CMC Director
1 week ago
Neurocrine Biosciences San Diego, United StatesWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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Sr. Dir/Director of Regulatory CMC
6 days ago
BioPhase San Diego, United StatesRemote - Candidates must be located in the United States - Ideally Southern California · The Sr. Director/Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the pre ...
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Sr. Dir/Director of Regulatory CMC
1 week ago
BioPhase San Diego, United StatesRemote - Candidates must be located in the United States - Ideally Southern California · The Sr. Director/Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the pr ...
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Director, Clinical Pharmacology
1 week ago
Equillium San Diego, United StatesThe Director of Clinical Pharmacology will lead the development and implementation of clinical pharmacology strategies for small molecules and biologics within the company's portfolio. They will offer expertise in analyzing pharmacokinetics, absorption, distribution, elimination ...
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Artiva Biotherapeutics San Diego, United States**About Artiva** · **Job Summary** · The Manager, GxP Validation, Calibration, and Engineering, is responsible for developing the Validation and Calibration functions at Artiva, which include managing consultants and contractors to support operation activities such as facility bu ...
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Clinical Dynamix, Inc. San Diego, United StatesAbout the Role: · Seeking a highly motivated and talented biologics leader within CMC (antibodies, gene therapy) in the areas of upstream and downstream API development, optimization and manufacture. The successful candidate will work on research and development of biologics proc ...
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Senior Director of Regulatory Affairs
2 weeks ago
Biophase San Diego, CA, United StatesRemote - Candidates must be located in the United States - Ideally Southern California · The Senior Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparati ...
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Kumquat Biosciences San Diego, United States: · Location: San Diego, CA 92121 · Position type: Full time · Job Code: KB-CMC-XX · Required education: Ph.D. Degree (preferred) /Master's Degree · Area(s) of expertise desired: Analytical chemistry or related field · Description · Kumquat Biosciences is committed to the discove ...
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Viking Therapeutics San Diego, United Statesread more " · Purpose of Role: · This position reports to the Vice President of pharmaceutical development. The associate research associate/scientist will contribute to the ongoing efforts to develop first-in-class or best-in-class therapies for metabolic and endocrine disorders ...
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Senior Director
1 week ago
BioPhase San Diego, United StatesThe Senior Director overseeing Drug Product Development will lead the integration and supervision of all aspects of product development, encompassing pre-formulation sciences, formulation development, device development, and packaging development. A key responsibility will be the ...
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Shelby American Inc San Diego, United StatesLocation: · San Diego, CA 92121 · Position type: · Full time · Job Code: · KB-CMC-XX · Required education: · Ph.D. Degree (preferred) /Master's Degree · Area(s) of expertise desired: · Analytical chemistry or related field · Description · Kumquat Biosciences is committed to ...
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Kumquat Biosciences Inc San Diego, United StatesJob Description · Job Description Description: · Location: · San Diego, CA 92121 · Position type: · Full time · Job Code: · KB-CMC-XX · Required education: · Ph.D. Degree (preferred) /Master's Degree · Area(s) of expertise desired: · Analytical chemistry or related field · ...
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Kumquat Biosciences Inc San Diego, United StatesJob Description · Job DescriptionDescription:Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founders to translate innovative ...
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Vice President, Regulatory Affairs
3 days ago
Device Search Group San Diego, United StatesWe are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). · As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background ...
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ANAPTYSBIO San Diego, United StatesJob DescriptionJob Description AnaptysBio Inc · All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, gene ...
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Sr. Director Regulatory Affairs
3 days ago
EPM Scientific San Diego, United StatesSenior Director Regulatory Affairs · San Diego, California · Compensation: $200,000-307,000 + Bonus + Equity · Company Summary: · We are partnered with an Cell Therapy focused company looking to revolutionize the way we approach cell therapy within Oncology as well as other Thera ...
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Senior Clinical Study Manager
1 week ago
BioSpace San Diego, United StatesJob Details · Position Summary · This position is accountable for all operational activities related to planning, executing/conducting and reporting out of assigned clinical study in support of AnaptysBio product development portfolio. The Senior Clinical Study Manager (Sr. CSM) ...
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Senior Clinical Study Manager
1 week ago
AnaptysBio, Inc. San Diego, United StatesApply · Description · Position Summary · This position is accountable for all operational activities related to planning, executing/conducting and reporting out of assigned clinical study in support of AnaptysBio product development portfolio. The Senior Clinical Study Manager (S ...
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Sr. Director, Regulatory Affairs
1 week ago
AnaptysBio Inc San Diego, United StatesAnaptysBio Inc · All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legall ...
Vice President Regulatory CMC - San Diego, United States - Dennis Partners
Description
Our client is a leading provider of non-opioid pain management and regenerative health solutions.They are seeking a Vice President Regulatory CMC to lead CMC Regulatory strategies for their commercial and development programs, and oversee an established team.
This is replacing the current VP who is retiring in January.With three marketed products and a strong pipeline, this company offers a passionate, small-company environment, with the opportunity to wear many hats.
Now is an exciting time to join this growing organization and help advance patient careResponsibilities :
Develop and lead implementation of CMC regulatory strategy to ensure timely and successful achievement of key Regulatory milestones for programs in development
Ensure effective post-approval Regulatory response and compliance for commercial products.
Directly oversee the Regulatory CMC group and provide support for manufacturing facilities in the US and UK.
Oversee the CMC regulatory new product development function in supporting formulation and preclinical development programs, including new IND, sNDA, NDA and other filings in the US and globally.
Work with internal and external manufacturing and commercial partners in support of US and ex-US regulatory filings for products.Identify, develop, implement and maintain global CMC regulatory procedures and systems.
Lead and oversee the preparation of CMC Regulatory documents and filings in all phases of development and post-approval.
Hire, manage and develop CMC Regulatory Affairs staff to ensure they deliver expected levels of excellence.
Collaborate with all functional areas of the company, especially Manufacturing, Quality, and R&D area.
Develop and implement regulatory strategies that will shorten approval times and improve product labeling.
Oversee the management of marketed products, ensuring all reporting obligations are met for both the FDA and other regulatory bodies.
Liaise effectively with domestic and international regulatory agencies.Participate in regulatory interactions with and presentations to regulatory agencies, customers, and partners.
Prepare and/or monitor the preparation of high quality, timely regulatory submissions.
Ensure conformance to commitments to various health agencies including FDA, EMA, MHRA, and ROW authorities.
Plan future resource and budget needs to ensure continued strong CMC regulatory support to match company growth.
Provide organizational support to the SVP of Regulatory Affairs to ensure effective communication within the department and with senior members of the organization.
Background and Qualifications:
Bachelor's degree in a scientific discipline such as chemistry, biology, pharmacy, or engineering. Advanced degree preferred.
Minimum of 15 years of progressively responsible experience in Regulatory CMC for drugs in development and approved products.
At least 8 years of experience managing people.
Must have Regulatory CMC experience with sterile products and small molecule drugs. Experience with biologics and gene therapy programs a plus.
Regulatory experience with Medical Devices desirable but not required.
Ability to identify emerging Regulatory issues and initiate actions.
Strong experience working with FDA required. Experience with EMA, Health Canada, and other global health authorities preferred.
Demonstrated knowledge of global (U.S., EU, UK, and ICH) regulatory requirements and the ability to apply knowledge, both strategically and operationally to develop projects and marketed product regulatory issues
Expert working knowledge of regulations and specific experience in CMC regulatory affairs, and the ability to support multiple products.
Interpersonal, Leadership, and Soft Skills:
Proven ability to hire, build, and lead a Regulatory CMC team.
Demonstrated strong negotiating and problem-solving skills.
Proven ability to manage multiple projects, set priorities and meet deadlines.
Demonstrated excellent technical writing skills.
Excellent verbal and written English communication skills.
Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.
The successful candidate will have a results/problem solving orientation supported by strong project planning and leadership skills.
This is a hybrid/onsite position in the San Diego Area. Local candidates are preferred but open to remote candidates who are willing to travel regularly. Relocation package possible for the right candidate.
The budgeted salary range for this position is $290,000 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 renumeration.#J-18808-Ljbffr
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