Regulatory Writer I

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for researching, creating, and refining materials for regulatory submissions to the FDA, spanning from pre-clinical stages to clinical trial phases 1 through 4.

• Collaborates effectively with Clinical Project Managers, Clinical Trial Associates (CTA), and various cross-functional teams.

• Identifies and implements timeline strategies for clinical, nonclinical, and CMC activities.

• Coordinates, authors, and develops drug applications and submissions to support clinical programs.

• Provides significant visibility and insight into FDA regulatory standards, Good Clinical Practice (GCP), ICH guidelines, and/or eCTD format.

• Authorship and compilation of FDA and Ex-US regulatory applications and submissions.

• Assists in gathering scientific and regulatory information to draft submission documents.

• Collaborates with data management and clinical teams to evaluate protocol development and interpret clinical trial results.

• Responsible for contributing to project timelines and achieving regulatory milestones.

• Ensures clear communication of commitments to team members.

• Leads multiple concurrent projects, with support from the Principal or Regulatory Manager.

• Formats and edits regulatory documentation for inclusion in INDs, CTAs, and other global submissions.

• Supports the timely preparation and distribution of regulatory submission documents.

⛳️ Requirements

• Master’s degree in applied sciences, life sciences, or communications.

• At least 1 year of experience in medical, regulatory, or clinical writing, or equivalent training and experience, including relevant coursework.

• Capable, with oversight, of writing, editing, or facilitating the completion of all clinical regulatory document types, including eCTD documents or similar, as well as protocols for Early Phase, Phase II, or Phase III trials.

• Ability to analytically assess and interpret clinical and scientific data; skilled at defining data presentation to communicate key messages developed by clinical and therapeutic teams.

• Goal-oriented, with the capability to establish detailed timelines for project completion and ensure efficient, timely delivery.

• Exceptional communication, interpersonal, negotiation, and project management abilities.

• Strong attention to detail, complemented by excellent organizational, research, and investigative skills.

• Adaptable to a dynamic environment; proven ability to multitask and meet deadlines and targets under pressure.

• Strong time management skills, with the capacity to handle multiple projects simultaneously.

• Ability to thrive in a team environment, while also being effective working independently.

• Proficiency in multiple languages is an advantage.

🏝️ Benefits

• Health insurance.

• 401K plan with company match.

• Flexible PTO.

• Unlimited sick time.

• 14 company-paid holidays.

• Adoption and fertility assistance.

• 16 weeks of paid parental leave.

• Company-paid life and disability insurance.

• Remote workspace and wellness reimbursement.

• Employee assistance program.

• Opportunities for career development.

• Chances to collaborate with colleagues worldwide.

• Opportunity to research innovative ophthalmic therapies.