
Global Regulatory Affairs Strategist
15 hours ago
Key Responsibilities:
- Develop and direct global regulatory strategies covering clinical, non-clinical, and CMC aspects.
- Lead the preparation, review, and approval of submission dossiers for regulatory authorities including US FDA, EMA, Health Canada, Australia's TGA, and ANVISA (Brazil).
- Provide strategic guidance on regulatory pathways related to CMC changes and ensure appropriate regulatory compliance.
- Collaborate with cross-functional teams including Quality, Manufacturing, Clinical, and R&D to ensure timely and compliant regulatory submissions.
- Manage timelines and coordinate with regulatory agencies to facilitate approvals.
- Participate in client interactions, trainings, and regulatory development initiatives as required.
- Lead and manage the regulatory affairs team, driving productivity and compliance.
Qualifications & Skills:
- 12 to 15 years of relevant experience in regulatory affairs, preferably within the pharmaceutical or related industries.
- Proven experience in developing and implementing regulatory strategies at a global level.
- Strong proficiency in preparing and submitting regulatory documentation to major health authorities (US FDA, EMA, Health Canada, TGA, ANVISA).
- Deep understanding of regulatory compliance requirements and industry best practices.
What We Offer:
Competitive salary package that reflects your skills and experience, excellent career opportunities for growth and professional development, and a dynamic work environment that encourages innovation and collaboration.
About This Role:
This is an exciting opportunity for an experienced Global Regulatory Affairs Strategist to join our organization and lead our regulatory affairs team. As a key member of our team, you will be responsible for developing and directing global regulatory strategies, leading the preparation and submission of regulatory documents, and collaborating with cross-functional teams to ensure timely and compliant regulatory submissions.
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