Senior Specialist (CMC) Regulatory Affairs

MoonLake TX; Cambridge; Hybrid; GBP 50,000 - 75,000; Full time

Job summary

A dynamic biotech company is seeking a Senior Specialist in Regulatory Affairs CMC in Cambridge. The role involves preparing regulatory CMC documents, collaborating with Technical Operations, and ensuring compliance with FDA and EMA regulations. The ideal candidate has a life sciences degree, at least 3 years of experience in CMC Regulatory Affairs, and strong attention to detail. Flexibility for hybrid work is provided.

Benefits

Opportunity for learning and growth

Contribute to impactful projects

Flexible work-life balance

Clear career progression path

Qualifications

• Minimum 3 years experience in CMC Regulatory Affairs.
• Experience in preparation of CMC sections for INDs and CTAs required.
• Working knowledge of FDA, EMA, and ICH regulations.

Responsibilities

• Prepare and finalize regulatory CMC documents for submissions.
• Collaborate on regulatory submissions requiring CMC content.
• Maintain awareness of current regulatory requirements.

Skills

Attention to detail

Time management

Communication on basic science

Education

First degree in life sciences

Advanced degree (PhD or Masters)

Job description

Job Purpose

As a Senior Specialist in Regulatory Affairs CMC, you are responsible for supporting the development and tracking of high-quality regulatory CMC and device documentation in alignment with MoonLake's development programs, working closely with Technical Operations colleagues.

Your profile

Major Accountabilities:

• Prepare, edit, and finalize regulatory CMC documents related to DS, DP, and device required for regulatory submissions e.g. Module 3 BLA and IND, IMPD amendments, responses to questions, and annual reports.

• Collaborate with internal Technical Operations colleagues and external organizations to support timely execution of regulatory submissions that require CMC content, contributing to planning activities as needed.

• Support the tracking and maintenance of regulatory filings and databases related to CMC submissions.

• Ensure all documents comply with applicable regulatory requirements (FDA, EMA, ICH) and internal standards.

• Ensure consistency across documents using company templates and style guides.

• Support QC and review processes to maintain accuracy and quality.

• Contribute to the development and optimization of processes, SOPs, and templates for controlled documents.

• Maintain awareness of current regulatory requirements and precedents in the CMC regulatory landscape.

Job Requirements

Education: First degree in life sciences required; advanced degree (PhD or Masters) preferred.

Experience:

• A minimum of 3 years experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry or consultancy.

• Experience and knowledge in preparation of CMC sections for INDs, CTAs, and marketing applications is required.

• Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations.

• Experience working with recombinant proteins is highly desirable.

• Experience working with drug-device combination products is highly desirable.

Skills/knowledge/behavioural competencies:

• An understanding of the drug development life-cycle from clinical trials to marketing is required.

• Ability to understand and clearly communicate on topics of basic science is essential.

• Strong attention to detail, structured work style, and time management.

• Commitment to high-quality and timely deliverables.

Work Location: 2 days a week in our brand new Cambridge or Porto Office(s).

Why us?

An exciting job opportunity awaits you!

MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What we offer:

Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.

Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.

Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.