Regulatory CMC Manager, Cell and Gene Therapy
Location
Europe
Posted
1 day ago
Salary
0
Seniority
Senior
Job Description
Regulatory CMC Manager, Cell and Gene Therapy
Syneos Health
• Support the execution of cell and gene therapy global regulatory CMC strategies for marketed and development products • Contributes to the preparation and submission of regulatory CMC documentation • Provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs • Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies • Contributes to the development of global regulatory CMC strategies for commercial products • Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions • Provides regulatory CMC guidance to cross-functional teams and key stakeholders • Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Job Requirements
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
- Experience in the preparation, including writing, of CMC submissions
- Strategic thinking and strong problem solving skills
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Capable of strategic thinking with ability to resolve complex and ambiguous situations
- Sound knowledge of cGMP, FDA, EMA, ICH
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
Benefits
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
Related Guides
Related Categories
Related Job Pages
More Therapist Jobs
Role Description Our client is seeking a highly organized, detail-oriented, and compassionate Patient Care Coordinator to support a busy rheumatology practice specializing in the treatment of autoimmune and musculoskeletal conditions. This role is ideal for someone with a healthcare background who enjoys working closely with patients, providers, and healthcare teams while supporting both clinical and administrative operations. - Play a critical role in patient intake, medical documentation, appointment coordination, insurance verification, prior authorizations, and ongoing patient communication. - Comfortable working within electronic medical record systems, maintaining accurate patient information, supporting providers with clinical documentation, and ensuring patients receive timely and professional assistance throughout their care journey. - Strong communication skills, attention to detail, and a commitment to patient care are essential for success in this position. Qualifications - Previous experience as a Medical Assistant, Medical Receptionist, Medical Administrative Assistant, Medical Scribe, Nurse, Pharmacist, Pharmacy Technician, Patient Care Coordinator, or similar healthcare role. - Strong understanding of healthcare workflows, patient communication, and medical terminology. - Experience supporting providers in a clinical or medical office setting. Requirements - Experience working with EHR/EMR systems required; experience with NextGen EMR strongly preferred. - Comfortable updating patient histories, medications, allergies, diagnoses, and provider notes. - Strong documentation accuracy and attention to detail. - Experience with insurance verification, eligibility checks, and prior authorizations. - Excellent spoken and written English communication skills. - Professional, compassionate, and service-oriented demeanor. - Reliable laptop or desktop computer with high-speed internet connection (minimum 25 Mbps). - Noise-canceling headset and webcam for virtual meetings. - Quiet, professional workspace. Benefits - Access to world-class support for questions, guidance, contract matters, and client communication. - Optional secure VPN license to enhance privacy and security for client-related tasks. - Access to internal HIPAA compliance training, cybersecurity modules, and certification. - Access to proprietary training on communication, client management, productivity systems, and best practices. - Contractors may take U.S. holidays off according to the client’s needs and schedule. - Time off may be granted by your client; paid time off is optional and only if offered by the client. - Access to templates, workflow guides, productivity tools, and client-specific SOP support. - Optional performance-based incentives may be offered by some clients.
Mental Health Therapist, Licensed in New York
Sailor HealthGuiding older adults towards happier and healthier golden years.
• Deliver high-quality, evidence-based psychotherapy to older adults in a virtual setting. • Design personalized treatment plans to meet the unique needs of each patient. • Work independently while being part of a collaborative and supportive care team. • Manage electronic documentation efficiently using our streamlined EMR system. • Participate in regular team meetings, supervision, and training to ensure best practices.
Mental Health Therapist, Licensed in Maryland
Sailor HealthGuiding older adults towards happier and healthier golden years.
• Deliver high-quality, evidence-based psychotherapy to older adults in a virtual setting. • Design personalized treatment plans to meet the unique needs of each patient. • Work independently while being part of a collaborative and supportive care team. • Manage electronic documentation efficiently using our streamlined EMR system. • Participate in regular team meetings, supervision, and training to ensure best practices.
Mental Health Therapist, Licensed in Arizona
Sailor HealthGuiding older adults towards happier and healthier golden years.
• Deliver high-quality, evidence-based psychotherapy to older adults in a virtual setting. • Design personalized treatment plans to meet the unique needs of each patient. • Work independently while being part of a collaborative and supportive care team. • Manage electronic documentation efficiently using our streamlined EMR system. • Participate in regular team meetings, supervision, and training to ensure best practices.

