Senior Regulatory-CMC Technical Writer

Seuss+

As Senior Regulatory-CMC Technical Writer you will lead and coordinate the writing of regulatory documents.

Our client is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so, each function is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
 
Purpose of the role
Highly experienced Regulatory-CMC Technical Writer to lead and coordinate the writing of regulatory documents. The writer will be responsible for (co)-authoring documents, such as IMPDs, CMC sections of INDs and Module 3 sections for BLA/MAA submissions and authority scientific advice meeting packages, as well as environmental risk assessment documentation and summary documents.
 
Key result areas (major duties, accountabilities and responsibilities)
  • Authoring, coordinating and reviewing of CMC documents for CTAs/INDs; BLAs/MAAs; environmental risk assessment documentation; briefing books; health authority response documents
  • Lead review cycles in close collaboration with RA, CMC and GMP functions (process and product development, analytical development, manufacturing, quality control and GMP quality assurance)
  • Provide direction on content (i.e., data and text, including level of detail) and storyline of the CMC sections of submissions and authority question/answers
  • Develop documentation frameworks and define which source documents are needed to support submissions
  • Development of junior CMC R&D and GMP staff by providing technical guidance and support for source document writing and/or (co-)author source documents, supportive of CMC sections of regulatory filings
  • Project management/coordination of technical writing and reviewing activities between the internal team and external subject matter experts
  • Ensure that the documentation is of high quality and that potential issues are discussed with internal and external partners in a timely manner
  • In collaboration with regulatory affairs, ensure the accuracy and clarity of the regulatory documents and ensure that all documents meet relevant national, regional and global regulatory requirements
  • Support the RA team in ensuring compliance with current and emerging CMC regulations, guidance documents and industry standards
  • Develop and maintain IND/IMPD (and in the future M3 BLA/MAA) templates, dossier tracking sheets and health authority question& answer tracking sheets in close collaboration with RA
  • Establishing good communication and collaborative relationship with cross-functional colleagues in our global operating company
 
Qualifications & Skills
  • Relevant academic degree- holds a PhD (Bio-sciences e.g. biotechnology, virology, biochemistry, molecular biology, pharmaceutical sciences) with 6+ years of relevant work experience. Alternatively, holds MSc or PharmD with 10+ years of relevant work experience
  • At least 5 years’ experience from biotech/pharmaceutical industry, ideally within advanced therapy medicinal products (ATMPs), but at least biologicals or vaccines
  • Proven track record of involvement in successful IMPD/IND filings, substantial amendments, scientific advices, and other regulatory documents; having experience with GMO/ERA submissions, and BLA/MAA filings is an asset
  • Hands-on technical writing experience from major regulatory submissions, from a similar position for application submissions towards national competent authorities, European Medicines Agency (EMA) and US Food and Drug Administration (FDA)
  • Strong written and oral communication skills to summarize complex studies and a demonstrated ability to convey information in a clear and concise manner
  • Proficiency in English at a professional level, both written and spoken
  • Strong skills in MS Office, especially in MS Word
  • Has extensive knowledge and deep understanding of the global regulatory framework regarding biopharmaceuticals, preferably of ATMPs (EP, USP, ICH, WHO, EMA/FDA/PMDA guidelines)
  • Good understanding of process (USP/DSP, DS/DP) and analytical development, qualification and validation of biopharmaceuticals
  • Experienced in multiple areas from the following: insect cells/BEVS bioprocessing, rAAV, ATMPs is an asset
  • A well-organized working style, delivering high-quality and with attention to detail
  • Passion about working in collaborative, complex and fast-paced environment with a high sense of urgency and with the ability to “walk the extra mile”
  • Committed and inspired by the mission of our company to bring safe and effective innovative gene therapy products to patients.
 
Core competencies
  • Delivery oriented with a strong ability to lead
  • Autonomous thinker with a sense of urgency
  • Strategic thinker
  • High level of ownership of the assigned programs
  • Leader / team player with an attitude to mentor others
  • Flexible to act in a highly dynamic and demanding environment
  • Proven ability to work interdisciplinary
  • Proven experience of working in a complex global operating company