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- Tasks: Prepare and finalise regulatory documents for submissions in a dynamic biotech environment.
- Company: Join MoonLake Immunotherapeutics, a cutting-edge biopharmaceutical company focused on innovative treatments.
- Benefits: Enjoy remote work options, career growth opportunities, and a supportive learning environment.
- Why this job: Make a real impact in global healthcare while working with passionate professionals.
- Qualifications: A degree in life sciences and 3+ years in CMC Regulatory Affairs are required.
- Other info: Work hybrid in our new Cambridge or Porto offices, contributing to groundbreaking projects.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Senior Specialist (CMC) Regulatory Affairs
Join to apply for the Senior Specialist (CMC) Regulatory Affairs role at MoonLake Immunotherapeutics (NASDAQ: MLTX)
Senior Specialist (CMC) Regulatory Affairs
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Join to apply for the Senior Specialist (CMC) Regulatory Affairs role at MoonLake Immunotherapeutics (NASDAQ: MLTX)
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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.
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?
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.
About Us
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of the inflammatory disease, to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.
Further information is available at www.moonlaketx.com
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Senior Specialist (CMC) Regulatory Affairs employer: MoonLake Immunotherapeutics (NASDAQ: MLTX)
Contact Detail:
MoonLake Immunotherapeutics (NASDAQ: MLTX) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Specialist (CMC) Regulatory Affairs
✨Tip Number 1
Familiarise yourself with the latest FDA, EMA, and ICH guidelines relevant to CMC submissions. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the regulatory landscape.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in CMC. Attend industry conferences or webinars to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you successfully collaborated with technical teams on regulatory submissions. Highlighting your teamwork skills can set you apart from other candidates.
✨Tip Number 4
Showcase your understanding of the drug development lifecycle during interviews. Being able to articulate how your role fits into the bigger picture will demonstrate your strategic thinking and relevance to the position.
We think you need these skills to ace Senior Specialist (CMC) Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in CMC Regulatory Affairs, particularly in the pharmaceutical or biotechnology industry. Emphasise your familiarity with FDA, EMA, and ICH regulations, as well as any specific projects you've worked on that relate to drug-device combination products.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your background aligns with MoonLake Immunotherapeutics' mission. Mention specific experiences that demonstrate your ability to prepare and finalise regulatory documents, and your collaborative work with Technical Operations.
Highlight Relevant Skills: Clearly outline your skills related to attention to detail, structured work style, and time management. Provide examples of how these skills have contributed to high-quality deliverables in your previous roles.
Showcase Continuous Learning: Mention any recent training or certifications related to regulatory affairs or CMC processes. This shows your commitment to staying updated with current regulatory requirements and enhances your profile as a candidate who is proactive about professional development.
How to prepare for a job interview at MoonLake Immunotherapeutics (NASDAQ: MLTX)
✨Know Your Regulatory Frameworks
Familiarise yourself with the FDA, EMA, and ICH guidelines relevant to CMC submissions. Be prepared to discuss how these regulations impact your previous work and how you ensure compliance in documentation.
✨Highlight Your Collaborative Skills
Since the role involves working closely with Technical Operations colleagues, be ready to share examples of successful collaborations. Discuss how you’ve effectively communicated and coordinated with cross-functional teams in past projects.
✨Demonstrate Attention to Detail
Given the importance of accuracy in regulatory documents, prepare to showcase your meticulous nature. You might want to provide specific instances where your attention to detail made a significant difference in a project outcome.
✨Stay Updated on Industry Trends
Show that you are proactive about keeping up with the latest developments in the CMC regulatory landscape. Mention any recent changes in regulations or trends that could affect the industry and how you adapt to them.
