Senior Manager/Associate Director, Regulatory Writer

🔥 12 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $140k - $170k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Angitia Biopharmaceuticals

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

💰 $46M Series B on 2023-10

Healthcare • Consulting • Biotechnology

Angitia Biopharmaceuticals is a clinical-stage biotechnology company founded in 2018, focused on the discovery and development of breakthrough therapeutics for serious musculoskeletal diseases. With a strong emphasis on innovation, Angitia aims to address unmet medical needs through their pipeline of therapeutics, including treatments for conditions such as Osteogenesis Imperfecta and Osteoarthritis. The company is devoted to fostering a culture of respect and equality, and is committed to employee growth and career development while delivering effective therapies to help patients in need.

📋 Description

• Lead the development of strategic document plans supporting global regulatory submissions and health authority interactions • Serve as lead writer for protocols, protocol amendments, Investigator's Brochures, Clinical Study Reports, briefing packages, INDs and CTAs, Orphan Drug Designation applications, Pediatric Investigation Plans, Pediatric Study Plans, annual reports, development updates, and responses to health authority questions • Develop integrated document strategies across regulatory, clinical, nonclinical, safety, and CMC content • Lead document planning and review meetings with cross-functional project teams • Facilitate alignment among subject matter experts and resolve content issues to maintain timelines and document quality • Partner with Regulatory Affairs to support global regulatory strategies and agency interactions • Represent Regulatory Writing on project teams and governance meetings • Develop and maintain writing processes, templates, style guides, and document development standards • Improve writing workflows and submission readiness • Manage external medical writing vendors and contract writers as needed • Mentor junior writers and contribute to organizational writing capabilities • Coordinate document finalization and publishing activities for major submissions • Ensure compliance with ICH, FDA, EMA, PMDA, and other applicable regulatory requirements • Support preparation for regulatory meetings and agency interactions

🎯 Requirements

• Bachelor's degree in life sciences or related discipline • Minimum 10 years of medical writing or regulatory writing experience within biotechnology, pharmaceutical, or CRO environments • Demonstrated experience serving as lead writer for major regulatory documents • Extensive experience authoring and coordinating protocols, Investigator's Brochures, Clinical Study Reports, regulatory briefing documents, IND and CTA submissions, and health authority responses • Strong knowledge of ICH guidelines, Good Clinical Practice (GCP), FDA, EMA, and international regulatory requirements • Demonstrated ability to independently manage multiple complex writing projects simultaneously • Experience leading cross-functional teams through document development and review cycles • Advanced degree (PhD, PharmD, MD, MS) in a scientific discipline • AMWA certification • Experience supporting BLA, MAA, or NDA submissions • Experience in rare disease and pediatric development programs • Experience supporting biologics development • Experience managing external writing vendors and consultants • Bilingual English and Chinese proficiency

🏖️ 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