Senior Director Regulatory Affairs

Senior Director, Regulatory Affairs – Permanent – Boston, MA

Proclinical is seeking a Senior Director, Regulatory Affairs for a growing and exciting clinical-stage biotechnology company based in the Greater Boston, MA Area.

In this role, you will help drive forward their regulatory strategy and operational activities related to the company’s muscle disease programs. The person in this role must thrive working in a fast-paced environment where flexibility, accountability and fearless innovation are key. Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory and strategies. A shared passion for the company’s mission to bring transformative therapies to people living with serious muscle diseases is a must.

The position is based in the Greater Boston, MA Area in a hybrid work environment.

• Minimum of a bachelor\'s degree in life science or related discipline is required
• Minimum of 12 years of experience in regulatory strategy in a clinical-stage biotechnology company
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
• Experience in Health Authority Meetings
• Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus

• Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings.
• As a member of program teams, provide global regulatory guidance regarding requirements for clinical development and registration of pharmaceuticals.
• Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements.
• Manage timelines and preparation of meeting requests and briefing documents.
• Author/edit documents to support regulatory submissions.
• Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
• Support the organization with health authority meetings.
• Provide strategic guidance for and author applications related to expedited programs/ designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc.).

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

• Director

• Full-time

• Science
• Industries Biotech Research and Pharmaceutical Manufacturing