Regulatory CMC Manager, Cell and Gene Therapy
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Regulatory CMC Manager supporting global regulatory strategies and documentation for cell and gene therapy. Collaborating with cross-functional teams and providing regulatory guidance for product compliance.
Responsibilities:
- 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
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.
Similar Jobs
Outpatient Therapist – Part Time
Part-Time Remote Therapist delivering evidence-based outpatient care in mental health for Mindpath Health. Conducting evaluations, treatment planning, and utilizing secure telehealth platforms.
Registered Respiratory Therapist
Remote Registered Respiratory Therapist providing telehealth respiratory care for patients with chronic lung conditions. Flexible hours and collaboration with multidisciplinary teams for patient-centered care.
Licensed Clinical Social Worker – In-Home Therapy
Licensed Clinical Social Worker providing in-home therapy to patients with mental health concerns. Supporting individuals through therapy with a flexible work schedule option.
Virtual Behavioral Health Therapist – LCSW or LPC
Virtual Behavioral Health Therapist providing therapy services remotely at Iris Telehealth. Develop treatment plans, document care, and connect patients with community resources.
Outpatient Therapist, LCSW or LPC
Outpatient Therapist providing virtual therapy services to patients ages 4+ for Iris Telehealth. Collaborating in a multidisciplinary team while delivering high-quality behavioral healthcare remotely.
Clinical Applications Specialist – Radiation Therapist
Clinical Applications Specialist providing training and support to customers using radioactive therapy equipment. Managing clinical expectations and delivering training in a remote capacity.
Mental Health Therapist – Telehealth
Telehealth Mental Health Therapist providing remote psychological care for individuals licensed in North Carolina. Join Affect’s mission in accessible mental health treatment.
Field Gene Therapy Lead – Key Account Manager
Key Account Manager improving patient journey for gene therapy company Krystal Biotech. Engaging with stakeholders and ensuring drug administration by training HCPs.
Mental Health Therapist
Mental Health Therapist conducting remote therapy sessions for individuals, couples, and families at Talk NYC Psychotherapy. Must be licensed and follow telehealth practices remotely in New York State.
Mental Health Therapist, LCSW, LPC
Remote Mental Health Counselor at New Leaf Teletherapy providing therapy services to employees. Delivering remote therapy and documenting progress using online platforms.
Mental Health Therapist – Adult Teletherapy
Remote Mental Health Counselor providing therapy to working adults using teleconferencing tools. Must have an active clinical license and experience in mental health therapy.
RBT, ABA Therapy
Behavior Specialist using ABA therapy techniques to enhance communication and life skills in children. Engaging with kids in a dynamic, flexible environment through play and strategies.
Licensed Psychotherapist
Licensed Psychotherapist providing high-quality teletherapy from home as a 1099 contractor. Flexible scheduling and total clinical autonomy in a remote setup.
Clinical Review Therapist – Physical Health
Clinical Review Therapist performing clinical reviews of therapy services for Centene. Collaborating with management to enhance therapy service execution and compliance under organizational standards.
Outpatient Mental Health Therapist – Part Time
Outpatient Mental Health Therapist delivering virtual outpatient therapy for individuals affected by chronic conditions. Focus on supporting family caregivers and ensuring comprehensive care and support.
Telehealth Therapist – Contractor
Licensed Therapist providing high-quality telehealth care as independent contractors with Brightways Counseling Group. Enjoy flexible scheduling and robust administrative support as you work independently.
Customer Success Executive – Cell & Gene Therapy
Customer Success Executive managing pharmaceutical client accounts for cell and gene therapies at McKesson. Responsible for customer satisfaction, account management, and business growth.
Licensed Therapist
Licensed Therapist providing remote support for substance use disorder in Washington State. Flexibility to work remotely while focusing on individual and group therapy for clients.
Occupational Therapist
Part-time Occupational Therapist engaging with cancer survivors in a virtual environment. Developing treatment plans and facilitating evaluations to improve patients' quality of life.
Psychotherapist – 1099 Independent Contractor
Licensed Psychotherapist providing teletherapy to diverse clients. Enjoy full schedule control and clinical autonomy in a remote setting.