- Contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings).
- Defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Company locations or contract manufacturing organizations (CMOs), or alliance partners.
- Identifies potential regulatory risks/challenges while ensuring Regulatory compliance.
- Authors autonomously the CMC sections of dossiers using Company templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards.
- Ensures delivery of sections in a timely manner.
- Manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
- Performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
- Maintains an up to date knowledge of Company's ways of working and SOPs and develops a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
- Authors other types of regulatory documents such as white papers, position papers, and briefing book.
- Help support non regulatory writing projects such as SOP and technical documents throughout the department.
Skills and Experience of a Technical Writer:
- Possess Chemistry, Manufacturing and Controls (CMC) experience and have some knowledge of CTD.
- Background of pharmaceutical manufacturing or quality control/quality assurance is a plus.
- Must have at least 5 years' experience in the industry.
- Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is a plus.
- A working knowledge of cGMP’s is desired.
- Experience with CMC documentation pertinent to various dosage forms and biological product is a plus.
- VEEVA experience
- Knowledge of US pharmaceutical Regulations is essential.
- Exposure to ex-US Regulations is desired, but not mandatory.
- BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).