Regulatory Affairs CMC Speciaist
Regulatory CMC Consultant
Contract: 18 Months
Location: Copenhagen, Denmark (Fully Remote)
Industry: Vaccines / Global Public Health
We are supporting a leading pharmaceutical organisation on a high-profile Tuberculosis (TB) vaccine development programme and are looking for an experienced Regulatory CMC Consultant to join the team on an 18-month contract basis.
This is a fully remote opportunity, working closely with global CMC, Regulatory Affairs, Manufacturing, and Quality teams to support regulatory strategy and submissions across the vaccine lifecycle.
Key Responsibilities
- Lead Regulatory CMC activities for a TB vaccine development programme.
- Prepare, review, and manage Module 3 documentation for global regulatory submissions.
- Support interactions with health authorities and answer regulatory queries.
- Collaborate with CMC development, manufacturing, analytical, and quality teams to ensure submission readiness.
- Drive regulatory strategy for chemistry, manufacturing, and controls throughout development and lifecycle management.
- Support variation filings, responses to questions, and regulatory maintenance activities.
Required Experience
- Strong Regulatory CMC experience within the pharmaceutical or biotechnology industry.
- Proven background supporting vaccine, biologics, or complex biologic product submissions.
- Experience authoring and reviewing Module 3 documentation.
- Understanding of global regulatory requirements across major markets.
- Experience working on infectious disease, vaccine, or public health-focused programmes is highly desirable.
- Ability to work independently within a global, cross-functional environment
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