Director of Regulatory Affairs CMC

BlueRock Therapeutics; Halifax Regional Municipality; On-site; CAD 80,000 - 120,000; Full time

Job summary

Join a leading engineered cell therapy company dedicated to transforming lives through innovative cellular medicines. In this pivotal role, you will provide regulatory CMC leadership for groundbreaking cell and gene therapy products, collaborating with diverse teams to navigate complex regulatory landscapes. Your expertise in biologics and cell therapy will be crucial in preparing quality submissions and engaging with health authorities globally. This dynamic environment values collaboration and innovation, offering you the opportunity to make a significant impact in advancing cutting-edge therapies for patients in need.

Benefits

Diversity and Inclusion Initiatives

Accommodations for Applicants with Disabilities

Awards for Workplace Culture

Flexible Work Environment

Qualifications

• 8-10+ years in Regulatory Affairs, focusing on biologics and cell therapy.
• Experience with global regulations and CMC submissions.

Responsibilities

• Lead regulatory CMC for cell and gene therapy products.
• Prepare quality dossiers for Health Authority meetings.
• Manage complex projects and engage with Health Authorities.

Skills

Regulatory Affairs CMC

Biologics Development

Cell Therapy Knowledge

Project Management

eCTD Submission Preparation

Interpersonal Skills

Education

Bachelor's Degree in Life Sciences

Master's Degree in Regulatory Affairs

Tools

Electronic Submission Systems

Job description

Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company utilizing its unique cell+gene platform to direct cellular differentiation and genetically engineer cells. Our goal is to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.

Founded in 2016, we leverage technological breakthroughs in cell biology and genetic engineering to develop, manufacture, and deliver innovative cell therapies across three therapeutic areas: neurology, cardiology, and immunology.

What Are We Doing?

Our science focuses on creating and directing the differentiation of universal pluripotent stem cells into authentic, functional cells as allogeneic cellular therapies. We also engineer these cells to produce enzymes, antibodies, and other proteins for therapeutic benefits. We are committed to advancing cellular and gene therapies to impact patients' lives positively.

We seek collaborative individuals who thrive in a dynamic culture and are dedicated to advancing cutting-edge therapies.

Position Overview

This role reports to the Vice President of Regulatory Affairs and Medical Writing. The incumbent provides regulatory CMC leadership for cell and gene therapy products, including preparing quality dossiers for Health Authority meetings, INDs/CTAs/IMPDs, and marketing applications in the U.S. and internationally. The role involves collaboration with technical CMC teams and program teams, and participation in the Global Regulatory Strategy subteam. Experience in neurology, ophthalmology, or cardiovascular areas and knowledge of global regulations for cell therapy are desired.

Responsibilities

1. Lead or represent regulatory CMC on matrix teams for pipeline products.
2. Provide strategic guidance on regulatory requirements for cell and gene therapy CMC.
3. Manage multiple complex projects independently.
4. Coordinate workflows related to Health Agency interactions, including briefing documents and responses.
5. Engage with Health Authorities for CMC submissions and issues, under guidance.
6. Identify and resolve strategic regulatory issues.
7. Interpret global regulations, identify opportunities and risks, and anticipate paradigm shifts.
8. Review and assess change controls from a regulatory perspective.
9. Prepare and manage global CMC submissions, ensuring thoroughness and timeliness.
10. Collaborate effectively with diverse teams.
11. Utilize electronic systems for dossier creation and tracking.
12. Support departmental initiatives and projects.

Minimum Requirements

1. Strong background in Regulatory Affairs CMC within a global pharmaceutical/biotech company, with expertise in biologics and cell therapy development, including US and international regulations.
2. 8-10+ years of experience in Regulatory Affairs, CMC, and related areas, preferably in biologics and cell/gene therapy products.
3. Experience with combination products and device filings is a plus.
4. Proven experience in preparing regulatory submissions following eCTD format.
5. Leadership in regulatory CMC discussions with global authorities.
6. Experience in development, manufacturing, and testing of cell therapeutics is highly desirable.
7. Ability to develop and execute complex regulatory strategies.
8. Technical understanding of manufacturing and quality control assays.
9. Strong interpersonal and collaboration skills across technical teams.
10. Excellent written and communication skills, detail-oriented, and computer literate.
11. Willingness to travel up to 25% within US/Canada, with limited EU travel possible.

Company Culture & Additional Info

BlueRock has received multiple awards for workplace culture and diversity, including Boston Business Journal's Best Places to Work 2023. We are committed to diversity and inclusion and support accommodations for applicants with disabilities.

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