Regulatory affairs specialist Empleos en Knoxville tn
Última actualización: hace 1 día
Thor Life Sciences has partnered with a leading [biotechnology / pharmaceutical] company dedicated to developing innovative therapies to address unmet medical needs.
We are committed to excellence in ...Mostrar másÚltima actualización: hace 6 días
It’s what drives us to innovate.To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more ...Mostrar másÚltima actualización: hace 4 días
The Contract Specialist is responsible for managing the lifecycle of contracts critical to our 3PL operations.This role focuses on agreements with carriers, shippers, and other service providers.It...Mostrar másÚltima actualización: hace 2 días
TeamHealth is named among the "150 Top Places to Work in Healthcare" by Becker's Hospital Review.The World's Most Admired Companies" by Fortune Magazine and one of America's 100 Most Trustworthy Co...Mostrar másÚltima actualización: hace 1 día
At Gary Yeomans Ford, we strive to make every customer a customer for life.Happy employees make happy customers, and we reward individuals who are ready to work hard and stay motivated.Every e...Mostrar másÚltima actualización: hace 19 días
The Activity Specialist is responsible for planning, organizing, and facilitating daily activities at an assigned KCDC residential property.
The incumbent plans and supervises daily activities and m...Mostrar másÚltima actualización: hace 1 día
A company is looking for a Senior Manager / Associate Director in Regulatory Affairs CMC.Key ResponsibilitiesContribute regulatory CMC expertise to product development and registration for small mole...Mostrar másÚltima actualización: hace 2 días
This job is responsible for leading large projects and initiatives related to the risk case management and intake activities of Highmark Health in support of a broad range of frameworks and oversig...Mostrar másÚltima actualización: hace más de 30 días
Regulatory & Quality Compliance Manager (m / f / d).The internal Job Title is called.Global Product Center Manager (m / f / d) - Sterile Fluids (Medicinal Products).
Support as regulatory expert development...Mostrar másÚltima actualización: hace más de 30 días
The Authorization Specialist will be responsible for obtaining prior authorizations for medical services, procedures, and tests for patients in the ENT (Ear, Nose, and Throat) practice.This role en...Mostrar másÚltima actualización: hace 3 días)
At the Trust Company of Tennessee, we believe everyone can live confidently and reach their financial goals.Would you like to be part of a team that works with individuals, families, businesses, an...Mostrar másÚltima actualización: hace 19 días
AAMCI is seeking a dynamic person to join our team as a Leasing Agent / Receptionist at a 199-unit Section 8 / Tax Credit community in Knoxville, TN.
Full time : Monday thru Friday 8am to 5pm.The communi...Mostrar másÚltima actualización: hace 3 días
Pay will be determined based on related work experience above required.To be considered in determining pay, all related work experience must be listed on the application.
Required Documents Needed t...Mostrar másÚltima actualización: hace 16 días
Do you want to join us in helping to fight the world’smost threatening diseases and enabling access to care for more people aroundthe world? At Siemens Healthineers, we pioneer breakthroughs in hea...Mostrar másÚltima actualización: hace más de 30 días
Senior leader to advance BCBSA’s legislative and regulatory policy solutions and market positioning in Medicare, Medicaid, Duals, and Children's Health Insurance Program, impacting the tens of mill...Mostrar másÚltima actualización: hace más de 30 días
Taking care of people is at the heart of everything we do, and we start by taking care of you, our valued colleague.A career at Sedgwick means experiencing our culture of caring.It means having fle...Mostrar másÚltima actualización: hace 12 días
Outlier helps the world’s most innovative companies improve their AI models by providing human feedback.Are you an experienced Math Expert who would like to lend your expertise to train AI models? ...Mostrar másÚltima actualización: hace 5 días
REMOTE – Registration Specialist.Contract Position, 5 days per week, from 9am-6pm EDT with one-hour lunch.Registration Specialist opportunity with the possibility of becoming a permanent posi...Mostrar másÚltima actualización: hace más de 30 días
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Quick Apply
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Registration Specialist
GrahamKnoxville, TNQuick Apply
Director of Regulatory Affairs
THOR CompaniesKnoxville, TN, United StatesHace 6 días
Tipo de contrato
- A tiempo completo
Descripción del trabajoAdvanced degree (Ph.D., Pharm.D., or M.S.) in chemistry, pharmaceutical sciences, or related field preferred. Minimum of [10+] years of experience in Regulatory Affairs, with a strong focus on CMC. Proven track record of successful regulatory submissions and interactions with global health authorities (FDA, EMA, MHRA, PMDA, etc.). In-depth knowledge of CMC regulatory requirements, ICH guidelines, and global regulations. Experience with [biologics / small molecules / cell and gene therapy] CMC development and lifecycle management. Strong leadership, strategic thinking, and problem-solving skills. Excellent communication, negotiation, and interpersonal skills. Ability to work collaboratively in a fast-paced, dynamic environment.
Company Overview :
Thor Life Sciences has partnered with a leading [biotechnology / pharmaceutical] company dedicated to developing innovative therapies to address unmet medical needs. We are committed to excellence in research, development, and regulatory compliance to bring life-changing products to patients worldwide.
Position Overview :
We are seeking a highly experienced Director of Regulatory Affairs - CMC to lead the development and execution of CMC regulatory strategies. This role will be responsible for ensuring compliance with global regulatory requirements, supporting product development and lifecycle management, and liaising with regulatory authorities. The ideal candidate will have a strong background in CMC regulatory affairs, with expertise in [biologics / small molecules / cell and gene therapy] and experience managing regulatory submissions across multiple markets.
Key Responsibilities :
- Develop and implement global CMC regulatory strategies to support product development, registration, and post-approval changes.
- Lead the preparation, review, and submission of high-quality CMC sections of regulatory filings (IND / CTA, BLA / NDA / MAA, variations, supplements, annual reports, etc.).
- Provide strategic regulatory guidance to cross-functional teams, including R&D, Quality, Manufacturing, and Clinical, to ensure alignment with regulatory expectations.
- Serve as the primary point of contact with health authorities for CMC-related matters, including meetings, queries, and negotiations.
- Monitor and interpret global CMC regulatory requirements, trends, and guidelines to ensure compliance and assess potential impact on company projects.
- Lead interactions with external partners, CMOs, and contract laboratories to ensure regulatory compliance of outsourced activities.
- Support due diligence and business development activities by assessing regulatory risks and opportunities.
- Mentor and develop junior regulatory professionals within the organization.
Qualifications & Experience :