Director, Regulatory

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July 28

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Precision Medicine Group

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Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

📋 Description

• Provide regulatory strategy and support for all regulatory and ethics submission in relation to Clinical Trials and drug development including Health Authority interaction • Establish operational objectives and assignments for assigned team members • Oversee, review and provide strategic input on applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and expedited pathways • Ensure budgets and plans meet corporate requirements • Provide ICH/GCP/Regulation guidance, advice and training to internal and external clients

🎯 Requirements

• 10+ years or more relevant regulatory affairs experience in CRO, Pharma, Biotech or related industry • Extensive and broad knowledge and experience of all aspects of drug development process, including subject matter expertise in regulations and guidelines (including but not limited to: NA, EMA, APAC, national authorities and IHC/GCP/GMP) • Proven track record of supporting client development activities leading regulatory pharmaceutical product development and managing complex regulatory clinical programs • Previous line management experience • Computer literacy (MS Office/ Office 365) • Fluent in English • Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC (or equivalent) certification/Masters in Regulatory Sciences • Experience in functional management including experience in delegating while fostering cohesive team dynamics • Possesses understanding of financial management