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- Tasks: Lead CMC technical writing and ensure compliance with global regulations for innovative therapies.
- Company: Join a cutting-edge biotech firm focused on developing novel medicines for severe immune disorders.
- Benefits: Enjoy a full-time role with opportunities for collaboration and professional growth in a dynamic environment.
- Why this job: Be part of a mission-driven team making a real impact on patients' lives through groundbreaking treatments.
- 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.
Associate Director – CMC Technical Writing
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, specification, 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.
Seniority level
Director
Employment type
Full-time
Job function
Manufacturing, Quality Assurance, and Science
Industries
Pharmaceutical Manufacturing
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Associate Director - CMC Technical Writing employer: RRxCo.™
Contact Detail:
RRxCo.™ Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director - CMC Technical Writing
✨Tip Number 1
Make sure to 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 pharmaceutical industries, especially those who have experience in CMC technical writing. Engaging with them can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully managed CMC documentation and regulatory submissions. Highlighting your achievements will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to collaborate effectively with cross-functional teams. Be ready to share how you've worked with different departments to achieve regulatory milestones, as this is crucial for the role.
We think you need these skills to ace Associate Director - CMC Technical Writing
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Associate Director - CMC Technical Writing position. Understand the key responsibilities and required qualifications, especially focusing on regulatory strategy and CMC lifecycle maintenance.
Highlight Relevant Experience: In your application, emphasize your experience in CMC and any specific work with biologics or monoclonal antibodies. Provide examples of your previous roles where you authored CMC sections in regulatory filings.
Showcase Collaboration Skills: Since the role requires working closely with cross-functional teams, include examples in your application that demonstrate your ability to collaborate effectively in a dynamic environment. Mention any relevant projects where you worked with Regulatory Affairs or Quality teams.
Tailor Your Documents: Customize your CV and cover letter to reflect the specific skills and experiences mentioned in the job description. Use keywords from the posting, such as 'regulatory submissions', 'CMC activities', and 'global regulations' to make your application stand out.
How to prepare for a job interview at RRxCo.™
✨Showcase Your Regulatory Expertise
Be prepared to discuss your experience with regulatory strategy and operational execution. Highlight specific examples where you've successfully navigated CMC regulations and contributed to regulatory submissions.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working closely with various teams, share instances where you've effectively collaborated with cross-functional teams. Emphasize your ability to communicate complex data clearly and work towards common goals.
✨Prepare for Technical Questions
Expect questions related to CMC lifecycle maintenance and global regulatory requirements. Brush up on your knowledge of IND Module 3 sections and IMPDs, and be ready to discuss how you would handle specific regulatory challenges.
✨Communicate Clearly and Confidently
Exceptional written and oral communication skills are crucial for this position. Practice articulating your thoughts clearly and confidently, especially when discussing technical documents and regulatory guidance.
