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- Tasks: Lead CMC technical writing and ensure compliance with global regulations for innovative therapies.
- Company: Join a cutting-edge biotech focused on developing novel medicines for severe immune disorders.
- Benefits: Collaborate with dynamic teams and contribute to life-changing treatments in a growing industry.
- Why this job: Be part of a mission-driven company making a real impact on patients' lives through innovative therapies.
- Qualifications: Bachelor's degree in science, 8+ years in CMC, and strong knowledge of global regulations required.
- Other info: Experience with biologics and monoclonal antibodies is strongly preferred.
The predicted salary is between 60000 - 84000 £ per year.
Job Description
RRxCo is partnered exclusively with a clinical-stage Biotechnology Company that develops novel medicines for severe immune disorders. Focused on the field of auto-immune disorders, our client is set to develop several assets over the coming years.
Summary
The individual will be a highly motivated and experienced Associate Director, CMC Technical Writer, to join a dynamic and growing team. The ideal candidate will have a proven track record in regulatory strategy and operational execution.
As the Associate Director, CMC Technical Writer you will report directly to the VP Head of CMC and will be instrumental in driving our CMC activities, ensuring compliance with global regulations, and contributing to the successful development and commercialization of innovative therapies.
You will collaborate closely with cross-functional teams, including CMC, Regulatory, and Quality to advance our pipeline and bring life-changing treatments to patients.
Essential Functions
- Author, review, and manage high-quality, compliant CMC source and regulatory documents (including IND Module 3 sections and IMPDs) for use in Regulatory submissions.
- The position will be focused on CMC and will need a good understanding of CMC lifecycle maintenance activities across EU and ROW markets.
- Work collaboratively with RA colleagues and SMEs to interpret and summarize complex data.
- Prepare and coordinate the review and approval of submission-ready documents.
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Perform regulatory assessment of CMC changes, identify global regulatory requirements, and evaluate supporting documentation to assess acceptability and identify potential risks.
- Provide interpretation of regulatory guidance documents, regulations, and directives and advise CMC regarding their applicability and impact on internal programs.
- Perform technical review of certificate of analysis, analytical test methods, specifications, product development reports, Master Batch Records (MBR), validation protocol/report, and stability protocol/report/data.
- Represent CMC on regulatory activities in cross-functional project teams and maintain collaborative partnerships with stakeholders.
Education
- Bachelor\’s degree in a scientific discipline.
- 8+ years of experience in CMC, minimum of 5 years of experience with biologics.
- Experience with monoclonal antibodies & biologic-device combination products strongly preferred.
- Strong knowledge of current Global CMC regulations, including CTD format and content of CMC regulatory submissions.
- Demonstrated experience authoring CMC sections in Module 3 sections and IMPD of regulatory filings required.
- Ability to read, analyze and interpret technical documents and health authority regulations.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones.
- Exceptional written and oral communication skills.
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Associate Director - CMC Technical Writing employer: ZipRecruiter
Contact Detail:
ZipRecruiter Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director - CMC Technical Writing
✨Tip Number 1
Familiarize yourself with the latest global CMC regulations and guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the biotechnology and regulatory fields. Attend industry conferences or webinars where you can meet potential colleagues and learn more about the current trends and challenges in CMC technical writing.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your ability to manage complex CMC documents and collaborate with cross-functional teams. Highlighting these experiences can set you apart during the interview process.
✨Tip Number 4
Research the company’s pipeline and recent developments in their therapeutic areas. Being knowledgeable about their projects will allow you to ask insightful questions and show your genuine interest in contributing to their mission.
We think you need these skills to ace Associate Director - CMC Technical Writing
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Associate Director - CMC Technical Writing position. Familiarize yourself with the specific skills needed, such as experience with regulatory submissions and knowledge of CMC lifecycle maintenance.
Tailor Your CV: Customize your CV to highlight relevant experience in CMC and regulatory writing. Emphasize your track record in authoring CMC sections and any experience with biologics, especially monoclonal antibodies and combination products.
Craft a Compelling Cover Letter: Write a cover letter that showcases your motivation for the role and how your background aligns with the company's mission. Mention specific experiences that demonstrate your ability to collaborate with cross-functional teams and manage regulatory documents.
Highlight Communication Skills: Since exceptional written and oral communication skills are essential for this role, provide examples in your application that illustrate your ability to convey complex information clearly and effectively, particularly in a regulatory context.
How to prepare for a job interview at ZipRecruiter
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of global CMC regulations and the CTD format during the interview. Be prepared to discuss specific examples of how you've navigated regulatory submissions in the past, especially related to IND Module 3 sections and IMPDs.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working closely with various teams, share experiences where you successfully collaborated with CMC, Regulatory, and Quality teams. Emphasize your ability to interpret complex data and how it contributed to project success.
✨Prepare for Technical Questions
Expect technical questions regarding CMC lifecycle maintenance activities and the assessment of CMC changes. Brush up on your knowledge of analytical test methods, specifications, and validation protocols to confidently answer these queries.
✨Communicate Clearly and Effectively
Given the importance of communication skills in this role, practice articulating your thoughts clearly. Prepare to explain how you would advise on regulatory guidance documents and their impact on internal programs in a concise manner.
