Remote Regulatory CMC Manager, Cell & Gene Therapy

Syneos Health, Inc.; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

The Chemistry Manufacturing Controls Manager will support regulatory CMC strategies for cell and gene therapy products and assist in the preparation and submission of regulatory CMC documentation. This role provides regulatory support and guidance to cross-functional teams to ensure global regulatory requirements are considered and incorporated into development and commercial programs.

Responsibilities include reviewing CMC sections of submissions, developing global CMC strategies, and guiding

Qualifications

• Strong interpersonal skills to exchange complex information with others and to guide others.
• Proficiency in regulatory guidelines (FDA, EMA, Health Canada and ICH).
• Experience in the preparation, including writing, of CMC submissions.
• Strategic thinking and strong problem solving skills.
• Ability to communicate clearly and timely with cross-functional teams.
• Strong planning and prioritization abilities across management levels.
• Capability to resolve complex and ambiguous regulatory situations.
• Sound knowledge of cGMP, FDA, EMA, ICH.

Responsibilities

• Reviews CMC sections of regulatory submissions and interacts with regulatory agencies.
• Develops global regulatory CMC strategies for commercial products.
• Collaborates with regulatory colleagues on submissions and strategies.
• Provides regulatory CMC guidance to cross-functional teams and stakeholders.
• Assesses regulatory topics, including change controls, deviations, and investigations.

Skills

Interpersonal skills

Regulatory guidelines

CMC submissions

Strategic thinking

Communication

Planning & prioritization

Complex problem solving

cGMP knowledge

Education

Bachelor's degree in life sciences

Job description

The Chemistry Manufacturing Controls Manager will support regulatory CMC strategies for cell and gene therapy products and assist in the preparation and submission of regulatory CMC documentation. This role provides regulatory support and guidance to cross-functional teams to ensure global regulatory requirements are considered and incorporated into development and commercial programs.

Responsibilities include reviewing CMC sections of submissions, developing global CMC strategies, and guiding