Manager/Sr. Manager, Technical Writing - CMC Regulatory Affairs

Manager/Sr. Manager, Technical Writing

• CMC Regulatory Affairs

Philadelphia, PA

About the Position

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.

Responsibilities Include

• Authors, reviews, and assists with submission of CMC documentation for INDs, IMPDs, BLAs and MAAs for cell and gene therapy programs.

• Authors, reviews, and assists with completion of technical documentation to support CMC Technical organization (e.g. technical transfer documentation, regulatory request for information, etc.).

• Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones, and document deliverables.

• Ensures accuracy, completeness, and compliance of regulatory submissions with regulatory requirements and company standards.

• Participates in CMC change controls to ensure released products are manufactured in agreement with established regulatory submissions and regulatory guidance.

• Works with technical teams to convert technical data and results into reports in support of regulatory submissions.

• Reviews and edits documents including those authored by others both internally and externally.

• Is a collaborative team player participating in both internal and external project team meetings as needed and offers proactive solutions and advice to team members.

• Remains compliant with company training, and authors and/or reviews departmental (CMC and regulatory) SOPs as needed.

• Identifies opportunities for process improvements and efficiency enhancements in CMC-related activities.

• Implement best practices and lessons learned to optimize regulatory processes and streamline project execution.

• Performs other activities as assigned.

Required Qualifications

• Degree in Biological Sciences, Chemistry, Chemical Engineer or equivalent;

• Senior Manager: BS or MS with 6 years' experience or Ph.D. and 2 years' experience in a technical writing capacity

• Manager: BS or MS with 3-5 years' experience or Ph.D. and 0 years' experience in a technical writing capacity

• Familiarity with the key regulatory requirements and guidelines for drug development and manufacturing, including FDA, EMA, and ICH guidelines.

• Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPD, INDs, MAAs, NDAs, and BLAs, is preferred.

• Ability to critically analyze, synthesize, and present complex information in well-constructed documents.

• Working knowledge of drug/biologics CMC development, data analysis, and tech transfer.

• Ability to support multiple projects and to prioritize work independently.

• Ability to comply with company and/or industry style guides and templates.

• Ability to guide and train others in the writing of technical documentation.

• Ability to work effectively in a cross-functional team environment.

• Fluent written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy.

• Advanced MS Skills in Word, Excel, Powerpoint, Viso and Adobe Pro

• Confidence to present to management, peers, and scientific or business collaborators.

• Strong written and verbal communication skills.

• Strong team orientation and passion for continuous self-development.

• Experience in the biotech industry or in a startup industrial setting is preferred.

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