Director, Regulatory Writing

About the role

You are passionate and dedicated to your work, with a commitment to overcome challenges and deliver on our potential to develop transformative therapies for patients and their caregivers. You bring energy and enthusiasm to your role, while recognizing that a steady and consistent effort is required to successfully develop novel medicines. Most importantly, while experience within a Regulatory Writing department at a growing biotech is beneficial, a motivated attitude and commitment to collective success are paramount.

Responsibilities

• Leads the planning and management for the authoring of regulatory submission components from the pre-clinical through registration phase, including clinical protocols and amendments, Investigator's Brochures, Development Safety Update Reports, clinical study reports, health authority meeting requests and briefing documents, and summary documents for IND, CTA, CTR, and NDA submissions.
• Leverages and efficiently manages external resources to ensure efficient execution of regulatory writing activities while ensuring effective communication with internal contributors and stakeholders.
• Serves as a lead author and/or document expert to maximize quality and efficiency of critical deliverables.
• Represents Regulatory Writing on cross-functional teams, working in close partnership with subject matter experts, Regulatory Affairs, and Program Management.
• Expands processes and standards that are critical to Regulatory Writing, including development, maintenance, and improvement of SOPs, authoring guides, and project management tools.
• Collaborates with Regulatory Affairs team to support submission-related activities.
• Develop strong working relationships with Regulatory colleagues and cross-functional project teams, as well as external stakeholders, to support achievement of timelines and portfolio deliverables.

Requirements

• BS or MS with at least 7 years of increasing responsibility as a regulatory / medical writer; education in a scientific field is a plus.
• A strong work ethic, excellent communication skills, and a desire to work collaboratively with matrixed project teams.
• A demonstrated track record in medical writing within the pharmaceutical, biotech, or CRO industry, particularly in creating and updating documentation for clinical development.
• Experience working within a biotech company while managing external resources is a plus.
• Expertise with Microsoft Word and eCTD-compliant formatting requirements.
• Proficiency in organizing and interpreting complex scientific and clinical data.
• A strong understanding of the relevant ICH, GCP, and FDA regulatory standards governing regulatory documentation.
• Experience with rare diseases, pediatrics, genetic medicines, or leveraging expedited development pathways is strongly preferred. Experience within Duchenne muscular dystrophy or neuromuscular therapeutic areas is a plus.
• Excellent project management skills and the ability to work on multiple projects with tight timelines.
• A motivated and driven attitude, with a proactive work style and a results-oriented mindset.
• Integrity, a desire to learn and grow, and a commitment to excellence.

Benefits

• Comprehensive health, dental and vision coverage; life and disability insurance.
• 401(k) match.
• Paid, gender-inclusive parental leave.
• Holistic support for health and well-being.
• Education reimbursement.
• Discretionary time off and commuting benefits aligned to your working model.

Pay

The salary for this opportunity ranges from $220,000 – $249,711. The final base compensation offered will depend on several considerations which include but are not limited to a candidate’s skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range.