CMC Regulatory Strategy Lead — Global Submissions & Compliance
NCBiotech
NCBiotech is looking for a key leader to support Chemistry, Manufacturing and Controls (CMC) regulatory strategy. This role involves ensuring timely access to medicines through the management of complex CMC regulatory processes. The successful candidate will have a Bachelor's degree in life sciences and over six years of experience in CMC regulatory activities. This position supports a hybrid working environment in Durham, North Carolina. #J-18808-Ljbffr NCBiotech
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the CMC Regulatory Strategy Lead — Global Submissions & Compliance in Durham, NC vacancy
- ...Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...teams ensures compliance and drives innovation... ...FDA expectations and global standards. Prepare and... ...focus on IND and BLA submissions to the FDA. Experience...RegulatoryLocal area
$190k - $260k
...seeking a Director (Senior Director), Regulatory Affairs in Durham, NC. This role... ...and involves overseeing global regulatory strategies for drug development. The successful... ...will manage regulatory submissions and ensure compliance with global regulations while fostering...Regulatory- NCBiotech in Durham, North Carolina is seeking a Regulatory Affairs professional to lead Chemistry, Manufacturing, and Controls (CMC) for vaccines. You will ensure compliance with FDA regulations and manage regulatory submissions. The role requires collaboration with cross‑...Regulatory
$144.38k - $240.63k
...Position Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and... ...to prepare submissions and respond to regulatory... ...internally (for increased compliance, harmonization and... ...review and approval of global CMC applications....RegulatoryWork at officeLocal areaRemote workWorldwide- Patient Engagement Lead - Global Clinical Trial Recruitment and Retention... ...and retention (R&R) strategy and execution across clinical... ...meet sponsor expectations, regulatory requirements, and internal quality... ...The Company is committed to compliance with the Americans with...RegulatoryContract workImmediate start
$203k - $253k
...seeking a Senior Director, Strategic Regulatory Affairs & UDI, based in Morrisville, NC. This role leads global regulatory operations, ensuring compliance and supporting market access.... ...empower teams, develop organizational strategies, and partner with various functions...Regulatory- ...Durham, North Carolina, seeks a CMC Regulatory Lead to oversee regulatory strategies for vaccine projects. The role involves... ...cross-functional teams to ensure compliance with FDA regulations and to prepare comprehensive regulatory submissions. Candidates must have a Bachelor'...Regulatory
- Position Summary You will lead planning, compilation, and delivery of regulatory submission dossiers for... ...You will work closely with global submission teams, clinical, CMC, quality, publishing, and... ...under deadlines. Strong compliance mindset with high attention...RegulatoryWork at officeLocal areaRemote work
$93.5k - $121k
...and act swiftly to impact global eye health. We foster an inclusive... ...hire a Sr. Associate II, Regulatory Affairs Strategy . This role is part of... ...will handle regulatory compliance and strategy activities for... .... Coordinate product submissions, renewals, and updates by...RegulatoryRelocationFlexible hours- ...Therapeutics is seeking a Manager of Global GMP Compliance based in Durham, North Carolina, to oversee... ...Systems and ensure compliance with regulatory standards. The ideal candidate should... ...in Quality Systems. The role involves leading compliance initiatives, managing recalls...Regulatory
- Implus in Durham, NC is seeking a Trade Compliance Lead to manage and implement trade compliance programs across North America. The role... ...full-time position offers a unique opportunity to contribute to the company’s regulatory compliance efforts. #J-18808-Ljbffr ImplusRegulatoryFull time
- ...seeks a Senior GPS & PV, Quality Control, Compliance & Training Manager in Durham, NC. This hybrid role involves leading the design and improvement of Global Patient Safety training programs, ensuring compliance with regulatory requirements, and supporting quality control...Regulatory
- Bioventus LLC in Durham, North Carolina is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for product marketing approvals and renewals. The role includes managing submissions and representing Regulatory during audits. The ideal candidate will...Regulatory
- Bioventus LLC is seeking a Senior Regulatory Affairs Specialist in Durham, NC. This role involves authoring and submitting regulatory applications... ...product clearance, maintaining registrations, and ensuring compliance with relevant regulations. The ideal candidate holds a Master’...Regulatory
- ...experts who are leading, shaping, and... ...Manager, Regulatory Affairs who can... ...who enjoys both strategy and execution.... ...updates, orphan submissions, and meeting... ...on clinical, CMC, device, nonclinical... ...to ensure global INDs/CTAs remain... ...and quality compliance by maintaining...Regulatory3 days per week
- ...JOB SUMMARY We are seeking a Senior Director, Head of Regulatory CMC with deep expertise in biological and cell therapy... ...products and CMC regulatory requirements. This role will lead strategy, compliance, and submissions for complex manufacturing processes and report to the...RegulatoryTemporary workLocal areaVisa sponsorship
- US01 Wolfspeed, Inc. in Durham, North Carolina is seeking a Head of Global Tax to lead the tax accounting function, including ASC 740 compliance and tax return preparations. This role requires strong expertise in corporate income tax and will involve overseeing tax initiatives...
- The Mosaic Company in Durham, North Carolina, is seeking a Director of Regulatory for Biological & Traditional Fertilizers. This role includes leading the global regulatory strategy, ensuring compliance for conventional fertilizer and biological product portfolios. The...Regulatory
- ...Senior/Director - Regulatory Affairs... ...worldwide regulatory strategy across... ...Affairs voice on global program teams... ...organizing and leading engagements with... ...of every submission sent to health... ...success and sustain compliance. Confirm... ...submissions containing CMC documentation....RegulatoryWorldwide
Implaion Recruiting
Durham, NC19 hours ago - Bioventus LLC in Durham is hiring a Regulatory Affairs Manager responsible for developing and executing global regulatory strategies. The ideal candidate will manage documentation... ...with regulatory agencies, and monitor compliance with international regulations. Applicants...Regulatory
- A leading medical device company located in Durham, NC is seeking a Regulatory Affairs Manager. This role is responsible for developing and executing global regulatory strategies to ensure compliance with various national and international regulations. Candidates should...Regulatory
- Alcon is seeking a Sr. Associate II, Regulatory Affairs Strategy to ensure compliance for innovative intraocular devices. This onsite role includes coordinating regulatory submissions, conducting independent research, and driving competitive advantage through regulatory...Regulatory
- Parexel International is hiring a Global Clinical Operations Leader/Clinical Trial Manager to oversee the execution... ...responsibilities include exhausting leadership in trial strategy, ensuring compliance with regulatory standards, and liaising with sponsors for operational...RegulatoryRemote job
- ...Manufacturing Co is searching for a Senior Director of Quality to lead the quality strategy for the MCS segment. The ideal candidate will be... ...senior leadership experience, with a focus on regulatory compliance and cross-functional collaboration. It offers an opportunity...Regulatory
- ...We are seeking a Lead Legal Analytics and... ...solve legal and regulatory related inquiries... ...and used in a global legal and regulatory... ...policies, strategies, and workflows.... ...information needed for compliance and operational efficiency... .... Lead submission, tracking, and reconciliation...RegulatoryTemporary workWork experience placementFlexible hoursShift work
$190k - $260k
...Senior Director), Regulatory Affairs Full... ...implementation of global regulatory strategies for assigned programs... ...with and in compliance with local and... ...activities, planning and leading: meetings with... ...compilation and submission of high‑quality... ...that include CMC documentation....RegulatoryFull timeLocal areaWorldwide$147.9k - $200k
...a diverse, inclusive global workforce with a culture... ...and experienced Compliance specialist to join our... ...compliance standards and regulatory requirements. This position... ...will report into the Lead Ethics & Compliance... ...Develop and implement strategies to mitigate identified...RegulatoryFull timeWork at officeLocal areaWork from homeWorldwide3 days per week- ...About Parexel Parexel is a leading global clinical development partner delivering insights... ...will lead the clinical operations strategy and execution of global clinical... ...standards while ensuring patient safety and regulatory compliance. You will serve as the primary...RegulatoryRemote workWorldwide
PAREXEL
Durham, NC4 days ago $235k - $255k
...Strategic Pricing and Deal Architecture to develop and execute pricing strategies that significantly impact business performance. This role... ...and offers opportunities for leadership development in a global context, alongside a competitive salary range of $235,000 to $2...Remote job- ...role involves embedding information security into business strategy and product delivery. Key responsibilities include advising... ...cybersecurity strategies. Strong engagement skills and knowledge of regulatory compliance are required. #J-18808-Ljbffr Syneos Health, Inc.Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Regulatory Strategy Lead — Global Submissions & Compliance. Be the first to apply!
Related searches
- regulatory contract Durham, NC
- regulatory coordinator Durham, NC
- regulatory technician Durham, NC
- food regulatory Durham, NC
- regulatory scientist Durham, NC
- regulatory law Durham, NC
- regulatory executive Durham, NC
- regulatory engineer Durham, NC
- regulatory Durham, NC
- regulatory compliance specialist Durham, NC