At a Glance
- Tasks: Lead regulatory strategy for groundbreaking cell therapy clinical trials and ensure compliance with global regulations.
- Company: Join Immix Biopharma, a leader in innovative treatments for AL Amyloidosis.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and career advancement.
- Why this job: Make a real difference in patients' lives by working on cutting-edge therapies.
- Qualifications: Bachelor's degree in life sciences and 3-5 years of regulatory affairs experience.
The predicted salary is between 113400 - 138600 $ per year.
The Associate Director of Regulatory Affairs will support the regulatory strategy and execution for clinical trials conducted under FDA/EMA/Other Regulatory agencies regulations. This role is responsible for preparing, submitting, and maintaining regulatory documents and ensuring compliance with all applicable laws and guidelines. The ideal candidate will demonstrate strong attention to detail, analytical skills, and knowledge of FDA/EMA/Health Canada/MHRA requirements for investigational products.
Key Responsibilities
- Assist in the preparation, review, and submission of INDs, amendments, and other regulatory filings.
- Monitor regulatory changes and communicate updates to relevant teams to ensure ongoing compliance.
- Coordinate with internal departments and external partners to gather necessary documentation for regulatory submissions.
- Maintain accurate records of regulatory correspondence and submissions.
- Support audits and inspections by regulatory authorities.
Qualifications
- Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred.
- 3-5 years of experience in regulatory affairs within the biopharmaceutical industry.
- Familiarity with FDA/EMA/Health Canada/MHRA regulations, clinical trial processes, and regulatory submission requirements.
- Strong written and verbal communication skills.
- Excellent organizational and project management abilities.
Preferred Skills
- Familiarity with eCTD submissions and regulatory software tools.
- Ability to work effectively in a collaborative, fast-paced environment.
- Attention to detail and analytical problem-solving skills.
Associate Director of Regulatory Affairs in Toronto employer: Immix Biopharma (Nasdaq: IMMX)
At Immix Biopharma, Inc., we pride ourselves on being an exceptional employer that fosters a culture of integrity and initiative. Our collaborative work environment encourages professional growth and offers unique opportunities to contribute to groundbreaking therapies in the biopharmaceutical industry. Located in a vibrant area, we provide our employees with competitive benefits and the chance to make a meaningful impact on patients' lives through innovative cell therapy solutions.
Contact Details:
Immix Biopharma (Nasdaq: IMMX) Recruitment Team
