Job Description

• Biotechnology
• Precision therapeutics for effective medical treatments

Our client is an innovative biotech Company that harnesses the latest technological systems to better understand and solve the underlying causes of diseases.

They are looking for an experienced Regulatory Affairs Manager/Senior Manager to join them. If you are passionate about regulatory affairs and would like to be part of a team that seeks to make a tangible impact by unlocking new treatment outcomes for diseases, we would love to speak with you.

Responsibilities

• Develop, execute, and communicate regulatory strategies for investigational drug candidate(s) in compliance with global filing plans and regional regulatory requirements.
• Review clinical trial documentation
• Provide regulatory expertise to optimize product development and expedite clinical studies in the US, and other jurisdictions if required.
• Prepare, or coordinate the preparation of, clinical / non-clinical sections of dossiers.
• Prepare, or coordinate the preparation of, meeting packages to the US FDA and other global regulatory bodies.
• Work with external partners and CROs to prepare and maintain regulatory filings to support multinational trials.
• Prepare, or coordinate the preparation of, designation requests and related requests to US FDA and other regulatory bodies.
• Manage external vendors for publishing regulatory submissions for investigational products.
• Act as a liaison between the company and health authorities (US FDA, EMEA, etc.) for assigned programs.
• Represent regulatory affairs at cross-functional development meetings and including sub team meetings.
• In collaboration with external partners may be required to support regulatory activities for in vitro diagnostics (IVDs).
• Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidelines in the context of new and ongoing development programs.

Requirements

• 4-5 years (Manager) or 5+ years (Senior Manager) of experience, including playing an integral role in developing regulatory strategies for cancer therapeutic development
• Familiarity with IND/CTA non-clinical enabling studies and clinical trials (design, results, conduct).
• Previous experience in regulatory affairs for IVDs would be an advantage.
• Knowledge of regulatory requirements, including ICH requirements and regional requirements and understanding of global regulatory trends.
• Capable of effectively leading the preparation of submissions and influencing colleagues across functions.
• Strong written/oral communication skills, engaging approach, and perseverance with a drive for results.
• Able to work independently with minimal direction and work well within cross-functional teams

We thank you for your interest and we regret that only shortlisted candidates will be notified. All resumes received will be used for recruitment purposes only. R1103318 EA Licence No: 11C3242