Regulatory Affairs Associate Director
1 week ago
SHATTUCK LABS, INC. is on the lookout for a skilled Regulatory Affairs Associate Director to play a pivotal role in shaping and executing global regulatory strategies for designated projects. This position entails managing regulatory submissions, facilitating discussions with regulatory bodies, and ensuring adherence to industry regulations and organizational policies.
Key Responsibilities:
- Deliver strategic regulatory insights for global pharmaceutical development initiatives
- Oversee the compilation and submission of regulatory documents
- Clarify and convey regulatory requirements to various stakeholders
- Stay informed about pertinent regulations and guidelines
- Support project timelines by meeting regulatory obligations
- Assist in the formulation of policies and procedures
- Collaborate effectively with both internal teams and external partners
Required Qualifications:
- Bachelor's Degree in a relevant field
- A minimum of five years of experience in regulatory affairs within the bio/pharmaceutical sector
- Demonstrated success in regulatory submissions
- Familiarity with FDA and ICH regulations
- Experience in drug development and clinical trial design
- Strong judgment in communicating issues
Preferred Skills:
- Experience in the development of biologics
- Background in oncology or immuno-oncology
- Scientific expertise in relevant disciplines
- Ability to excel in a dynamic work environment
- Experience across both early and late-stage drug development
- Recent involvement with BLA, NDA, and MAA submissions
-
Regulatory Affairs Associate Director
7 days ago
Durham, North Carolina, United States SHATTUCK LABS, INC. Full timeRegulatory Affairs Associate DirectorSHATTUCK LABS, INC. is in search of a skilled Regulatory Affairs Associate Director to play a pivotal role in shaping and executing global regulatory strategies for various projects. This position entails managing regulatory submissions, facilitating discussions with regulatory bodies, and ensuring adherence to applicable...
-
Senior Regulatory Affairs Manager
2 weeks ago
Durham, North Carolina, United States SHATTUCK LABS, INC. Full timeDirector / Associate Director of Regulatory AffairsSHATTUCK LABS, INC. is in search of a qualified Director / Associate Director of Regulatory Affairs to play a pivotal role in shaping and executing comprehensive regulatory strategies for various programs. This position entails managing regulatory submissions, facilitating discussions with regulatory bodies,...
-
Regulatory Affairs Specialist
1 week ago
Durham, North Carolina, United States Duke Health Full timeREGULATORY AFFAIRS SPECIALISTDuke HealthAn exciting position is open for a Regulatory Affairs Specialist at Duke Health. In this role, you will be tasked with executing study-specific regulatory and safety reporting procedures across various projects, ensuring compliance with applicable regulations, institutional guidelines, and study protocols under the...
-
Global Regulatory Affairs Director
4 days ago
Durham, North Carolina, United States GlaxoSmithKline Full timeJob Summary:We are seeking a highly skilled Global Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for developing and executing the appropriate regulatory strategy for assigned assets, across all stages of the product development and consistent with the Vaccines...
-
Lead Regulatory Affairs Specialist
2 weeks ago
Durham, North Carolina, United States Bioventus Full timeAre you prepared to contribute to a more active world? At Bioventus, we believe in the growth and development of our team members. We are committed to investing in your professional journey and encouraging you to excel. We appreciate the diverse perspectives and unique contributions of our colleagues, and our leadership is attentive to their needs. Our...
-
Principal Regulatory Affairs Consultant
2 weeks ago
Durham, North Carolina, United States Bioventus Full timeAre you prepared to contribute to a more active world? At Bioventus, we prioritize the growth and development of our team members. We believe in investing in our people and encouraging them to reach their full potential. Our diverse workforce is valued for its unique perspectives and contributions, and our leadership is committed to listening and fostering...
-
Senior Regulatory Affairs Coordinator
2 weeks ago
Durham, North Carolina, United States Duke University Full timeSchool of Medicine Founded in 1930, Duke University School of Medicine stands as the youngest among the nation’s premier medical schools. Ranked sixth nationally, the School is proud to foster an inclusive environment that nurtures exceptional learners, researchers, clinicians, and staff, promoting interdisciplinary collaboration to expedite the...
-
Regulatory Operations Manager
2 weeks ago
Durham, North Carolina, United States Duke Health Full timeSenior Regulatory Coordinator RoleJob Summary:We are seeking a highly skilled Senior Regulatory Coordinator to lead the regulatory and safety operations of a team conducting oncology clinical trials and research studies for our Cancer Institute's Clinical Research Program at Duke Health.Key Responsibilities:Oversee day-to-day regulatory operations for...
-
Regulatory Project Manager
2 months ago
Durham, North Carolina, United States GlaxoSmithKline Full timeSite Name: UK - London - New Oxford Street, Durham Blackwell StreetPosted Date: Jul We are seeking a highly motivated Regulatory Affairs professional to join our CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Group. Within Global Regulatory Affairs, the CMC organisation provides regulatory leadership to CMC teams encompassing Global Supply...
-
Durham, North Carolina, United States GlaxoSmithKline Full timeJob OverviewThe US Medical Affairs Lead for Belantamab Mafodotin is a critical role that requires a strong understanding of the pharmaceutical industry, medical affairs, and oncology. This position will lead the development and execution of the US Medical Affairs strategy and plans for Belantamab Mafodotin, ensuring alignment with commercial asset strategy...
-
Regulatory Compliance Specialist
2 weeks ago
Durham, North Carolina, United States Stefanini Group Full timePosition Overview:Stefanini Group is seeking a dedicated Regulatory Affairs Specialist - Technical Writer to support our esteemed client in the chemical manufacturing sector. This role is pivotal in ensuring adherence to regulatory standards through meticulous document management and technical writing.Key Responsibilities:Employ technical writing expertise...
-
Regulatory Compliance Specialist
2 weeks ago
Durham, North Carolina, United States Stefanini Group Full timePosition Overview:Stefanini Group is actively seeking a Regulatory Affairs Specialist - Technical Writer to support a prominent client in the chemical manufacturing sector. This role involves managing a high volume of documentation, ensuring compliance, and engaging in technical writing to facilitate regulatory data management.Key Responsibilities:Employ...
-
Compliance and Legal Affairs Specialist
2 weeks ago
Durham, North Carolina, United States Duke Full timePosition Overview:The Compliance and Legal Affairs Specialist plays a crucial role in supporting the investment operations of Duke. This position is integral to the legal and compliance division, focusing on the management of legal documentation, compliance initiatives, and corporate governance.Key Responsibilities:Oversee team duties and track the status of...
-
Regulatory Compliance Specialist
2 weeks ago
Durham, North Carolina, United States Stefanini Group Full timePosition Overview:Stefanini Group is seeking a dedicated Regulatory Affairs Specialist - Technical Writer to support a prominent client in the chemical manufacturing sector. This role involves managing extensive documentation, ensuring compliance, and performing technical writing tasks essential for regulatory data management.Key Responsibilities:Employ...
-
Associate Director
2 months ago
Durham, North Carolina, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Executive Director
6 days ago
Durham, North Carolina, United States Volunteers of America National Services Full timeAbout the RoleThe Executive Director is responsible for overseeing the overall operations of the Senior Community Care of North Carolina PACE organization. This includes directing staff to ensure efficient and effective PACE operations, meeting participant needs, and achieving organizational objectives.Key ResponsibilitiesOperational Leadership: Oversees and...
-
Medical Director, US Respiratory
4 days ago
Durham, North Carolina, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled Medical Director to join our team at GlaxoSmithKline. As a key member of our Medical Matrix Team, you will play a critical role in developing and executing medical strategies for our respiratory assets.Key ResponsibilitiesDevelop and Execute Medical Strategies: Collaborate with cross-functional teams to develop...
-
Durham, North Carolina, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Bioanalysis and Biomarkers Platforms team at GlaxoSmithKline. As a key member of our team, you will be responsible for leading the development and implementation of bioanalytical strategies and methods for our clinical studies.Key ResponsibilitiesMethod Development and Validation:...
-
Director of Senior Community Care
6 days ago
Durham, North Carolina, United States Volunteers of America National Services Full timeAbout the RoleThe Executive Director is responsible for overseeing the overall operations of the Senior Community Care of North Carolina PACE organization. This includes directing staff to ensure efficient and effective PACE operations, meeting participant needs, and achieving organizational objectives.Key ResponsibilitiesOperational Leadership: Oversees and...
-
Regulatory Compliance Associate
6 days ago
Durham, North Carolina, United States Cambrex Corporation Full timeAbout the RoleCambrex Corporation is seeking a highly organized and detail-oriented Quality Assurance Coordinator to support the assigned Quality Assurance team in various areas, including document archive management, data entry and trending, GxP documentation management, and general office support.Key ResponsibilitiesOrganize and inventory records in a...