Job summary:

The Regulatory Writer (Manager/Sr Manager level) contributes to the vision and goals of Global Regulatory Affairs (GRA) by:

Providing innovative scientific and regulatory vision, leadership, and oversight for products in development by defining aligned global regulatory strategies and activities for Angitia's developmental portfolio and accountable for non-clinical, clinical and safety content in global regulatory documentation.

Leading and coaching direct reports and vendors (as applicable).

Assuring a productive collaboration with key internal stakeholders, such as research, early and late-stage clinical development, safety, and project management leads, to ensure successful development, strategic alignment and execution of global regulatory strategies that result in successful applications for Angitia's product portfolio, from early development to Marketing Authorization (MA).

In collaboration with GRA colleagues and vendors, supporting the establishment and maintenance of high-quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies for Angitia.

The position will be working remotely with the potential to travel for team and client meetings.

Key responsibilities

• Prepare regulatory submissions to FDA across a diverse portfolio of product types (small molecule, biologics, combinations), development phases, and scientific disciplines (nonclinical, clinical, general regulatory and/or device).
• Lead the Authoring and review of regulatory documents [IMPDs, Scientific Advice Briefing Documents, Investigator Brochures, Clinical Study Reports, Protocols, Pediatric Investigation Plans, Pediatric Study Plans, Orphan Designation Applications, breakthrough designation applications, fast track designation Clinical Overviews (CTD Module 2.5) and Clinical Summaries (CTD Module 2.7), etc.]. Responsible for providing advanced expertise and support to Regulatory Management in the development and preparation of regulatory documents.
• Provide guidance to project team and work directly with team members in identifying and ensuring compliance with requirements for responses to request for information after major submissions to global regulatory authorities (INDs/CTAs, BLAs/NDAs).
• Support and, if requested, lead interactions with cross functional teams assigned to the development of specific response documents submission materials and will partner with submission manager to ensuring the accuracy and quality of submission-ready documents.
• Overall accountability for ensuring cross functional collaboration in the preparation of high-quality, accurate, clearly messaged, properly sourced regulatory documents.
• Understand, interpret, and share relevant guidance and where needed identify and or summarize other information sources (e.g., scientific literature, study summaries, figures, tables, graphs, health authority minutes).
• Prepare templates (with instructions to authors), develop writing style guidelines, and facilitate efficient team contributions to provision of requested/relevant data and information (compliant with relevant and current regulatory requirements).
• Partner with regulatory and external publishers to ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
• Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per relevant ICH and other guidance.
• Manage timelines for regulatory documents to achieve regulatory submission strategies.
• Ensure quality of regulatory submission documents at all stages of development Provide expertise and guidance on document design and principles of good medical writing to the department and product teams.

Education & qualifications

• Bachelor's degree required; advanced degree preferred.

• Doctorate degree OR Master's degree and 3 years writing Regulatory or scientific submission/documents experience OR Bachelor's degree and 5 years of writing Regulatory or scientific submission/documents experience, OR Associate's degree and 10 years of Writing Regulatory or scientific submission/documents experience, OR High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
• Language: English native or bilingual level Chinese would be a plus
• Experience with regulatory document writing (FDA briefing books, requests for orphan designations, requests for fast track, requests for breakthrough, pediatric plans, etc) or writing in peer reviewed journals.

• Expertise in interpretation of guidance documents and should be able to work independently using materials from previous interactions with healthcare authorities, literature, and clinical documentation (protocols, IB, treatment guidelines) to ensure development of timely, accurate and compliant, responses.
• American Medical Writing Association (AMWA) certification with a specialty in Pharmaceutical Writing is or equivalent training highly desirable.
• Experience in working with collaborative, cross-functional teams. Specifically, regulatory writing experience addressing responses to health authorities request for nonclinical, clinical, CMC or pharmacovigilance/safety requests for information.
• Working knowledge of statistical concepts and techniques.
• Excellent written and oral communication skills.
• Documented expertise in summarizing scientific content.
• Demonstrated attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
• Ability to summarize regulatory guidelines and apply them appropriately and understand and interpret clinical/non-clinical data from different sources.
• Experience in pediatric and rare disease drug development is greatly desired.

• Strong ethics and integrity.
• Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters.

Salary range：$110K to $140K