How to Apply
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Philadelphia, PA
Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing – CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes. The Manager/Sr. Manager, Technical Writing for CMC will interface with clinical, nonclinical and CMC personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, internal scientists/engineers). The Manager/Sr. Manager will work with Technical, Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements. This position requires a combination of strong technical writing capabilities, regulatory expertise, project management skills, and collaboration with cross-functional teams to achieve regulatory milestones and support the company's overall vision of bringing accessible cures for patients with autoimmune diseases.