GRA CMC Scientist

BioSpace; Waltham (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

CSL Behring in Waltham, MA, seeks two regulatory scientists to drive global CMC regulatory strategies for biologic products. You will partner with manufacturing, quality, and regulatory colleagues to ensure high-quality regulatory submissions that support development, registration and lifecycle management.

The role requires a degree in a scientific field and at least 3 years in biotech/pharma, with 1+ year in Regulatory Affairs.

Qualifications

• Degree in a scientific discipline such as Biotechnology, Biological Sciences, Chemistry, Pharmacy, or related field.
• Minimum 3 years’ biotech/pharma experience with at least 1 year in Regulatory Affairs.
• Experience with regulatory submissions and knowledge of regulatory frameworks (US/EU/Japan/CH/Australia).
• Fluent in English with strong communication and stakeholder management skills.
• Excellent planning, project management and ability to work across global cross-functional teams.

Responsibilities

• Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes.
• Coordinate the preparation, review, and maintenance of CMC regulatory documentation to support global submissions.
• Ensure regulatory dossiers remain accurate, current, and compliant throughout the product lifecycle.
• Partner with cross-functional technical teams to assess manufacturing, facility, equipment, and process changes and determine regulatory impact.
• Prepare and review regulatory content for submissions including marketing applications, clinical trial applications, lifecycle variations, and responses to health authority questions
• Provide regulatory input into development projects, product quality reviews, risk assessments, and change management activities.
• Interpret evolving global regulatory requirements and assess their impact on products and development programs.
• Support inspection readiness activities and contribute to continuous improvement of regulatory processes.
• Act as a key regulatory partner within cross-functional project teams, providing CMC expertise and strategic guidance.

Skills

Regulatory strategy

Global submissions

Communication

Project management

Cross-functional collaboration

English fluency

Regulatory awareness

Stakeholder management

Education

Science degree (Biotechnology/BioSci/Chemistry/Pharmacy)

Job description

The Opportunity

At CSL, our work is driven by a simple purpose: to save lives and protect the health of people around the world. We are seeking two regulatory scientists to be based at any of the following sites:

• Melbourne - Australia
• Broadmeadows - Australia
• Bern - Switzerland
• Waltham – United States

As the GRA CMC Scientist, in the relevant location, you will play a critical role in developing and executing global Chemistry, Manufacturing and Controls (CMC) regulatory strategies that support the development, registration, and lifecycle management of innovative biologic therapies. Working within a highly collaborative global environment, you will partner with technical experts, manufacturing teams, and regulatory colleagues to ensure high-quality, compliant regulatory submissions that enable patients to access life-changing therapies.

Your Responsibilities

• Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes.
• Coordinate the preparation, review, and maintenance of CMC regulatory documentation to support global submissions.
• Ensure regulatory dossiers remain accurate, current, and compliant throughout the product lifecycle.
• Partner with cross-functional technical teams to assess manufacturing, facility, equipment, and process changes and determine regulatory impact.
• Prepare and review regulatory content for submissions including marketing applications, clinical trial applications, lifecycle variations, and responses to health authority questions
• Provide regulatory input into development projects, product quality reviews, risk assessments, and change management activities.
• Interpret evolving global regulatory requirements and assess their impact on products and development programs.
• Support inspection readiness activities and contribute to continuous improvement of regulatory processes.
• Act as a key regulatory partner within cross-functional project teams, providing CMC expertise and strategic guidance.

Your Qualifications, Skills And Experience

• Degree in a scientific discipline such as Biotechnology, Biological Sciences, Chemistry, Pharmacy, or a related field.
• Minimum of 3 years’ experience in the biotech or pharmaceutical industry, with at least 1 year in Regulatory Affairs. Experience within Regulatory Affairs, CMC, manufacturing, quality, process development, or a related function.
• Understanding of regulatory requirements associated with biological medicinal products.
• Knowledge of regulatory frameworks within at least one key region (US, EU, Japan, CH, Australia). and experience preparing or contributing to regulatory submissions.
• Strong communication and stakeholder management skills including fluent in English.
• Excellent planning, project management, and organisational abilities to manage competing priorities.
• Analytical thinker with strong problem-solving capability.
• Ability to influence and collaborate across diverse, global teams.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.