Regulatory Affairs Specialist (CDMO)

仕事内容

Job Description: Regulatory Affairs Specialist (GMP - CDMO) at Candoo Pharmatech Company Inc.

Position Overview: We are seeking a highly skilled and motivated Regulatory Affairs Specialist with expertise in Good Manufacturing Practices (GMP) and Contract Development and Manufacturing Organization (CDMO) operations. As a Regulatory Affairs Manager at Candoo Pharmatech Company Inc., you will play a critical role in ensuring compliance with regulatory requirements and standards governing the development, manufacturing, and distribution of pharmaceutical products. Your responsibilities will include coordinating and managing regulatory activities, maintaining compliance documentation, and providing strategic guidance to support successful product registrations and regulatory submissions.

Key Responsibilities:

Regulatory Compliance: Monitor and interpret relevant GMP regulations, guidelines, and industry best practices to ensure compliance with local, regional, and international regulatory requirements.
Develop and implement regulatory strategies to support new product registrations, license renewals, and variations.
Conduct internal audits to assess GMP compliance, identify gaps, and recommend corrective actions to ensure continuous improvement.

Documentation Management: Prepare, review, and submit regulatory dossiers, applications, and reports to regulatory agencies within specified timelines.
Maintain accurate and up-to-date regulatory documentation, including product registrations, manufacturing licenses, and technical files.
Collaborate with cross-functional teams to gather necessary data and documentation for regulatory submissions, ensuring completeness and accuracy.

Regulatory Submissions and Approvals: Manage the preparation, compilation, and submission of regulatory documents, such as marketing authorization applications, variations, and responses to agency queries.
Track and monitor the progress of regulatory submissions and ensure timely responses to agency requests for additional information or clarification.
Liaise with regulatory agencies to address inquiries, resolve issues, and facilitate the approval process.

Quality Management: Collaborate with quality assurance and quality control teams to ensure compliance with GMP regulations and standards.
Support the development, implementation, and maintenance of quality systems and procedures to ensure regulatory compliance.
Participate in internal and external audits, as well as inspections by regulatory authorities, and assist in the resolution of findings.

Regulatory Intelligence and Training: Stay informed about new and emerging regulatory requirements, guidelines, and trends in the pharmaceutical industry.
Provide training and guidance to cross-functional teams on regulatory compliance, GMP principles, and documentation practices.
Foster a culture of regulatory awareness and continuous improvement across the organization.

Qualifications and Requirements:

• Bachelor’s degree in a scientific or related field; advanced degree preferred.
• Extensive experience (5+ years) in regulatory affairs within the pharmaceutical or biopharmaceutical industry, specifically in GMP and CDMO operations.
• Thorough understanding of GMP regulations, guidelines, and industry standards (e.g., FDA, EMA, ICH).
• Proven track record of successful regulatory submissions and approvals.
• Strong knowledge of regulatory requirements for drug development, manufacturing, and commercialization.
• Excellent written and verbal communication skills.
• Detail-oriented with exceptional organizational and project management abilities.
• Ability to work collaboratively in a cross-functional team environment.
• Proficiency in regulatory software, document management systems, and Microsoft Office Suite.

Join our dynamic and innovative team at Candoo Pharmatech Company Inc. as a Regulatory Affairs Specialist, and contribute to the successful development and commercialization of life-saving pharmaceutical products in a highly regulated environment.

Job Type: Full-time

Benefits:

• Company pension
• Dental care
• Extended health care
• On-site parking
• Paid time off
• RRSP match
• Vision care

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Mississauga, ON L5N 5L9: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor’s Degree (required)

Experience:

• CDMO: 3 years (preferred)

Work Location: In person