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Regulatory Writer

Remote (PST Zone) with occasional travel for team and client meetings

Position:           Regulatory Writer
Department:  Global Clinical Development
Location:          Remote (PST Zone) with occasional travel for team and client meetings
Reports To:     Executive Director, Global Regulatory Affairs

 

Summary

We are seeking a Regulatory Writer to bring their scientific and regulatory vision and leadership to our Global Regulatory Affairs team. The Regulatory Writer will play a key role in defining aligned global regulatory strategies and driving their execution toward successful regulatory submissions across Angitia’s developmental portfolio, from early development to Marketing Authorization. Effective execution of these strategies will require close collaboration with key internal stakeholders, external vendors, and global regulatory agencies to develop non-clinical, clinical, and safety content for global regulatory documentation. The ideal candidate brings deep knowledge of ICH guidelines and regulatory requirements, excels at navigating cross-functional dynamics, and thrives in a fast-paced, collaborative environment. This is a unique opportunity to help shape a growing organization and contribute directly to the advancement of novel therapeutics.


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).
  • Author, review, and provide subject matter expertise in the development of regulatory documents, including Scientific Advice Briefing Documents, CTD modules, Designation requests, and PIPs.
  • Lead and collaborate closely with cross-functional teams, submission managers, and external publishers to ensure timely, accurate, and compliant regulatory submissions and responses.
  • Interpret and communicate regulatory guidance, synthesizing insights from multiple sources to support compliant submissions.
  • Develop templates and writing style guidelines, ensuring consistency with ICH and other regulatory standards for grammar and formatting.
  • Manage timelines for regulatory documents to achieve regulatory submission strategies.

 

Qualifications

  • Bachelor’s degree in life sciences or related field with a minimum of 5 years of regulatory writing experience in the pharmaceutical, biotechnology, or CRO industry.
  • Advanced degree (PhD, PharmD) in life sciences, pharmacy, or related field is a plus.
  • Experience writing regulatory documents across nonclinical, clinical, CMC, and safety/pharmacovigilance areas, including FDA briefing materials, orphan designation requests, fast track and breakthrough applications, and pediatric plans.
  • Experience preparing responses to health authority requests for INDs, CTAs, NDAs, and BLAs, as well as writing peer-reviewed journal articles.
  • Strong understanding of regulatory guidance (e.g., FDA, ICH) and ability to work independently using complex source materials such as prior authority interactions, protocols, IBs, literature, and clinical documentation.
  • Highly skilled in writing clear, well-organized scientific content and summarizing complex nonclinical and clinical data, with strong command of grammar and keen attention to detail and quality.
  • AMWA certification in Pharmaceutical Writing or equivalent training is highly desirable.
  • Experience working in and leading cross-functional teams.
  • Working knowledge of statistical concepts and their application in regulatory.
  • Experience in pediatric and rare disease drug development is highly desired.
  • Strong ethics, integrity, and cross-cultural awareness.
  • Bilingual fluency in English and Chinese is a plus.

 

Salary Range: $100,000 to $130,000

 

About Angitia

Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis (Phase 2), osteogenesis imperfecta (OI) (Phase 1), and spinal fusion (Phase 3). Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group.

Learn more at www.angitiabio.com.

 

Benefits:

  • Medical, dental, and vision coverage for employees and their eligible dependents
  • 401(K) Retirement Plan with Company match
  • Company paid Long Term Disability Coverage
  • Company-paid life Insurance & AD&D Coverage
  • Voluntary Life Insurance & AD&D Coverage
  • Employee Assistance Program (EAP)
  • Company-paid Holidays
  • Vacation
  • Paid Sick Leave
  • Telecommunication Monthly Stipend
  • Work-From-Home Equipment Reimbursement

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