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Regulatory Affairs Cmc Officer
4 months ago
**Be part of something altogether life-changing**
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The Regulatory Affairs CMC Officer for Cytiva is responsible for leading CMC strategies for internal and partner programs.
This position is part of Global Regulatory Compliance in Marlborough and will be remote. At Cytiva, our vision is to advance future therapeutics from discovery to delivery.
**What you will do**:
- Lead development and execution of regulatory Chemistry, Manufacturing, and Controls (CMC) biomanufacturing strategies for internal and partner programs of all development phases, including varied programs in gene and cell therapy (CGT), antibody bioprocessing (mAb/biAb), mRNA products, and complex biologics.
- Proactively identifies CMC/cGMP issues and implements appropriate regulatory strategies to mitigate CMC dossier, QP, import/export, and other biomanufacturing regulatory documentation risks.
- Oversees activities for meetings with FDA and other regulatory authorities and leads negotiations and interactions with regulatory authorities on CMC matters.
- Leads cGMP CMC regulatory intelligence activities, including proactive communication of regulatory CMC/GMP expectations to internal and external stakeholders (including partners, customers, program teams, and quality stakeholders) to execute program objectives in compliance with applicable regulations.
**Who you are**:
- MS degree or higher from an accredited institution
- Minimum of 7 years experience working with global regulatory agencies and health authorities, including US FDA, EU EMA/Competent Authorities, and in other global regions
- Minimum of 7 years experience in Good Manufacturing Practices (GMP) for biological drug development, with significant Chemistry, Manufacturing, and Controls (CMC) and ICH module 3 experience with experience in cell therapy and gene therapy CMC preferred.
- Acts as a strong regulatory business partner that can engage with diverse cross-functional matric environments to develop regulatory strategy and drive deliverables.
**It would be a plus if you also possess previous experience in**:
- Ability to work effectively in electronic document management systems, e.g., Veeva Vault.
- Demonstrated ability to handle multiple projects/deliverables simultaneously.
At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.
The salary range for this role is $120,000-$150,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
