Regulatory CMC Manager Cell and Gene Therapy

Syneos Health, Inc.; Washington (District of Columbia); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Syneos Health is seeking a Regulatory CMC Manager for Cell and Gene Therapy to lead global regulatory CMC strategies and submissions for marketed and development products. You will collaborate with cross-functional teams to ensure global regulatory requirements are met and properly integrated into programs.

The role requires strong knowledge of FDA/EMA/ICH guidelines, experience in CMC submissions, and the ability to guide teams across functions to advance product development and

Qualifications

• Bachelor's degree in a life sciences field.
• Experience preparing regulatory CMC submissions.
• Strong knowledge of FDA, EMA, Health Canada and ICH guidelines.
• Excellent communication and project management skills.
• Ability to work with cross-functional teams globally.

Responsibilities

• 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

Skills

CMC submissions

FDA/EMA/ICH guidelines

Regulatory strategy

Cross-functional collaboration

cGMP knowledge

Education

Bachelor's degree in life sciences

Job description

Regulatory CMC Manager Cell and Gene Therapy

Updated: Yesterday

Location: Remote, DC, Colombia

Job ID:25108926-OTHLOC-7352-2DR

Description

Regulatory CMC Manager Cell and Gene Therapy

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

General Position Summary

The Chemistry Manufacturing Controls Manager will supportthe execution of cell and gene therapy global regulatory CMC strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation. This role also 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.

Key Duties & Responsibilities

• 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
• Providesregulatory 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

Required Education Level & Experience

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiencyin regulatory (FDA, EMA, HealthCanadaand ICH) guidelines
• Experience in the preparation, including writing, of CMC submissions
• Strategic thinking and strongproblem solvingskills
• Ability to collaborate and communicate in an open, clear, complete,timelyand consistent manner
• Strong senseof 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

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

CMC expertise in small molecule experience with support to Regulatory team with Global expansion on multiple markets. Veeva RIM authoring is required.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health ® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.