Job description

Position Summary:
Reporting to the Executive Director, Regulatory Affairs, the Manager/Sr. Manager, Regulatory Affairs will support the company’s regulatory affairs needed for IND/CTA/BLA/NDA filings and approvals. The Manager/Sr. Manager, Regulatory Affairs is a key member of project teams and is responsible for the managing the day-to-day tasks required to achieve regulatory goals across multiple programs. The Manager/Sr. Manager, Regulatory Affairs is expected to bring knowledge of the clinical development process and regulatory requirements, strong project management and vendor management skills, and excellent communication and writing skills to ensure that company submissions meet regulatory and company standards with high quality and within stated timelines. This role is onsite at least 3-days per week.

Essential Responsibilities:

• Lead interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology projects in a multi-functional team.
• Collaborate with internal staff to author and support submissions to achieve successful approvals of clinical trials and marketing applications (including INDs, CTAs, BLAs, MAAs, and NDAs).
• May include directly or indirectly supporting a variety of projects and submissions.
• Manage timelines and expectations to ensure a positive experience.
• Act as SME with deep knowledge of regulations for all aspects of pharmaceutical development including interpreting regulations and applying appropriate regulatory risk management strategies designed to identify potential risk, evaluate consequences, and provide solutions to address needs.
• Ensure compliance with all appropriate government regulations, industry guidelines, and best practices.
• Manage, oversee and/or prepare regulatory documents and submissions in accordance with Client requirements.
• Prepare presentations as needed.

Education and Experience Requirements:

• Bachelor’s or master’s degree in a scientific field.
• At least a minimum of 6 years of regulatory experience, especially in Clinical Regulatory Affairs for pharmaceutical and/or biotechnology products; experience with Phase 1 through Phase III products (IND/CTA) and/or marketing applications (US/EU) is highly desirable.
• Demonstrated experience supporting regulatory writing, electronic submission and format requirements.
• Proven experience in contributing to the preparation of INDs, CTAs, NDAs, MAAs and/or BLAs for submission to the Regulatory Agencies.
• Direct experience working with the FDA and other health authorities is highly desired.
• Must be able to cover all aspects of regulatory affairs including Development, CMC, and Operations; experience in clinical regulatory is highly desirable.
• Must be able to interpret trends in the FDA/EMA/ICH regulatory environment.
• Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
• Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
• Must be comfortable with ambiguity in a small, fast-paced environment.

Job Type: Full-time

Pay: $60.00 - $70.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• 6+ years of Clinical Regulatory Affairs for Pharma Products (Required)
• Direct working with FDA (Preferred)

Work Location: In person

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