Head of Regulatory Affairs
Company: Courpharma
Location: Skokie
Posted on: October 20, 2024
Job Description:
COUR is a clinical stage biotech company that is developing
technologies to revolutionize medicine and provide potential cures
for auto-immune patients. Our innovative nanoparticle platform aims
to address the root causes of autoimmune diseases, inducing
tolerance and preserving overall immune functionality.About the
roleWe are seeking an experienced and strategic Head of Regulatory
Affairs to lead our regulatory efforts and ensure compliance with
regulatory requirements across all stages of product development.
You will be responsible for shaping and executing regulatory
strategies, managing submissions, and serving as the primary
interface with regulatory agencies. Reporting to our Chief Medical
Officer, this is a high-impact leadership role where you will work
closely with cross-functional teams to bring innovative biotech
products to market.What you'll do
- Regulatory Strategy Development: Develop and implement
comprehensive regulatory strategies for all phases of drug and
biologic development, ensuring alignment with company objectives
and regulatory requirements.
- Regulatory Submissions: Lead the preparation, review, and
submission of all regulatory documents, including INDs, BLAs and
other regulatory filings. Ensure timely and successful
submissions.
- Agency Interaction: Serve as the primary liaison with
regulatory authorities, including the FDA, and potentially other
international agencies. Lead regulatory meetings, negotiations, and
communications to facilitate approvals and resolve issues.
- Compliance & Risk Management: Ensure compliance with all
relevant regulations, standards, and guidelines throughout the
product lifecycle. Identify potential regulatory risks and develop
mitigation strategies.
- Cross-Functional Collaboration: Partner with internal teams,
including R&D, CMC, clinical development, quality,
manufacturing, program management and legal to ensure regulatory
requirements are integrated into development plans and
operations.
- Regulatory Intelligence: Stay current on relevant changes in
regulatory environments, proactively applying changes to
decision-making and strategies as needed.QualificationsBachelors
degree (required) or advanced degree (preferred) in life sciences
(Ph.D., PharmD, or MS) or related field; a background in regulatory
science, law, or healthcare is a plus.Minimum of 10 years of
experience in regulatory affairs within the biotech or
pharmaceutical industry, including at a strategic
level.Demonstrated success in obtaining regulatory approvals (IND,
BLA) for biotech products, ideally in immunology and/or rare
diseases.In-depth knowledge of global regulatory requirements,
particularly FDA, and other major health authorities.Excellent
negotiation, communication, and interpersonal skills, with a proven
ability to interact effectively with regulatory agencies and senior
leadership.Strong leadership skills with the ability to set
direction for the function and guide programs through
approvals.Experience with regulatory submissions and compliance in
a fast-paced, evolving biotech environment.
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Keywords: Courpharma, Des Plaines , Head of Regulatory Affairs, Other , Skokie, Illinois
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