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Director, CMC
3 weeks ago
Zevra Therapeutics Boston, United StatesJob Description · The Director, CMC will develop and manage manufacturing and packaging operations for clinical and commercial drug substance and drug products at contract manufacturing (CMO) facilities. · Job Responsibilities · Manage and interface with CMOs (including person-in ...
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Director, Regulatory CMC
2 weeks ago
Kelly Flores Boston, United StatesSummary of Position: · The Director Regulatory CMC will be responsible for developing and delivering innovative regulatory CMC strategies for product development and approval. With limited guidance from the EVP Regulatory Affairs & Quality Assurance, the incumbent acts as the r ...
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Director, CMC Operations
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Taylor Strategy Partners Boston, United StatesInterested in joining a clinical-stage biotechnology company, focused on bringing new generation adjuvanted subunit vaccines to market? We combine excellence in protein and adjuvant biology to create vaccines of global importance. · Curevo Vaccine is dedicated to developing next ...
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Director, Regulatory Affairs Vaccines CMC
1 week ago
Takeda Pharmaceutical Company Ltd Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
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Regulatory CMC Director or Associate Director
4 weeks ago
Dennis Partners Boston, United StatesOur client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage ...
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Senior Director, Regulatory CMC
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X4 Pharmaceuticals Boston, United StatesSenior Director, Regulatory CMC · Reporting to: · Vice President, Regulatory Affairs · Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite y ...
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Director, Regulatory CMC, Cell
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Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory g ...
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Director, Regulatory Affairs Vaccines CMC
3 weeks ago
Takeda Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
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Director, Regulatory Affairs Vaccines CMC
3 weeks ago
Takeda Pharmaceutical Company Ltd Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
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Associate Director, CMC Biologics Drug Product
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Stratacuity Boston, United StatesAssociate Director, CMC Biologics Drug Product Location: Newton, MA (Onsite) Science: Monoclonal antibody therapeutics Job Overview: The Associate Director will lead CMC development activities and collaborate with internal and external partners to oversee and plan CMC development ...
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Associate Director, CMC Biologics Drug Product
2 weeks ago
Apex Systems Boston, United StatesJob#: · Job Description: · Associate Director, CMC Biologics Drug Product · Location: Newton, MA (Onsite) · Science: Monoclonal antibody therapeutics · Job Overview: The Associate Director will lead CMC development activities and collaborate with internal and external partners ...
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Associate Director, CMC Biologics Drug Product
4 weeks ago
Professional Diversity Network Boston, United StatesJob#: · Job Description · Associate Director, CMC Biologics Drug Product · Location: · Newton, MA (Onsite) · Science: Monoclonal antibody therapeutics · Job Overview: · The Associate Director will lead CMC development activities and collaborate with internal and external pa ...
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Associate Director, CMC Biologics Drug Product
4 weeks ago
Apex Systems Boston, United StatesAssociate Director, CMC Biologics Drug Product · Location: Newton, MA (Onsite) · Science: Monoclonal antibody therapeutics · Job Overview: The Associate Director will lead CMC development activities and collaborate with internal and external partners to oversee and plan CMC ...
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Sr. Manager/Associate Director, CMC Development
4 weeks ago
Internetwork Expert Inc Boston, United StatesJoin Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San Francisco office. · As a crucial member of our team, reporting directly to the Head of CMC, you'll play an integral role in ...
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Sr. Manager/Associate Director, CMC Development
4 weeks ago
Frontier Medicines Boston, United StatesJoin Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San Francisco office. · As a crucial member of our team, reporting directly to the Head of CMC, you'll play an integral role i ...
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Sr. Manager/Associate Director, CMC Development
3 weeks ago
Frontier Medicines Boston, United StatesJob Description · Job Description · Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San Francisco office. · As a crucial member of our team, reporting directly to the Head o ...
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Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: · The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and man ...
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Manufacturing Project Manager
1 week ago
Insight Global Boston, United StatesJob Title: Project Manager- Associate Director · Location: Boston, MA (seaport) · Pay Range: $60-75/hour (12 month contract to hire) · Must Haves: · In depth understanding of drug development and pharmaceutical sciences functional areas · Highly skilled at enabling goals of pro ...
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Business Development Director
4 weeks ago
Life Science People Boston, United StatesLSP is partnering with a CRO client of ours searching for a Business Development Director to become an integral part of their business development team. · The ideal candidate would have a strong success rate of achieving sales targets and would be responsible for maintaining and ...
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Director, Regulatory Affairs
3 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
Regulatory CMC Director - Boston, United States - Dennis Partners
3 weeks ago
Description
Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders.They are seeking a Regulatory CMC Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
Reporting into the Senior Director Regulatory CMC, you will work closely with cross-functional teams, CMOs, and Health Authorities. This company offers a science-based, entrepreneurial culture, excellent employee benefits, and flexible work arrangements. With their lead program going into global Phase three studies this year, now is an exciting time to join this growing organizationResponsibilities:
Provide regulatory CMC strategic leadership to support development of multiple innovative products including life-cycle management and post-marketing changes.
Prepare and submit high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (NDAs/MAAs).
Lead CMC-specific meetings and resolve CMC issues through negotiations with regulatory agencies.
Review and approve CMC technical reports as source documents, as per procedures, in coordination with Quality.
Develop CMC response strategies and submissions to health authorities.
In coordination with Regulatory Operations, manage completion of CMC submission documents and other assigned tasks within established timelines and with high quality.
Lead the preparation for CMC meetings with health authorities and develop CMC section of briefing packages.Shepherd proactive interactions with regulators; prepare and submit responses to CMC questions.
Support R&D and the Quality Group with regulatory agencies during cGMP and pre-approval inspections.
Provide critical review of all CMC information supporting regulatory applications, including CMC sections of Investigators' Brochure, SmPC, and labeling.
Assess proposed change controls (e.g., manufacturing process changes) and provide strategic regulatory guidance to enable regulatory and filing implementation.
Identify and assess CMC regulatory risks on key program strategies.
Prepare and deliver effective presentations for internal and external audiences.
Ensure productive interactions between Regulatory CMC, R&D, Quality, and Technical Operations, along with business partners and CMOs.
Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs.
Qualifications:
Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
Eight or more years in CMC Regulatory for small molecule pharmaceutical drugs.
Experience with drug-device combinations products (e.g., pre-filled syringes and injectables) and ophthalmic products highly desired but not required.
Must have regulatory CMC experience supporting both development projects and commercial products.
Experience writing CMC sections for INDs, CTAs, NDAs and supportive amendments or supplements.
Must have experience working directly with the FDA. Experience with global regulatory authorities (EMA, Health Canada, etc) a plus.
Strong knowledge of eCTD elements and structure and regulatory technical writing skills.
Strong knowledge of current Good Manufacturing Practices (GMP), drug development regulations and guidelines including ICH, and FDA guidelines
Proficient in Microsoft Office Suite (Outlook, Teams, Word, etc.) and other applications (e.g. Adobe Acrobat and eCTD viewers).
Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
Strong written and oral communication skills.
Detail oriented and well organized. Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Independently motivated and solution oriented.
Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
Able to be flexible and comfortable with ambiguity.
Candidates in the Greater Boston Area must be onsite 2-3 days a week. Remote candidates elsewhere in the Northeast may be considered and regular travel would be required.
The budgeted salary range for this position is US$200,000 to $225,000 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
