Manager/Senior Manager, Global Regulatory Affairs

Responsibilities

• Support the preparation, review, and submission of health authority documents as required, including marketing applications, responses to Agencies’ questions and requests, meeting requests, briefing packages, annual reports, etc.
• Represent GRA as a team member and provide relevant regulatory strategy into clinical, labelling, protocols, reports, presentations, and other documents.
• Cover the preparation, review and submission including responses to Agencies’ questions and requests, meeting requests, briefing packages, annual reports, etc.
• Identify and assess regulatory risks associated with assigned project responsibilities and assist in defining strategies to mitigate risks.
• Collaborate with Global/Regional and Local (country) counterparts to ensure global/regional regulatory strategy is defined and executed upon for all projects within area of responsibility.
• Manage submission plans and timelines to ensure approvals and development objectives are timely met.
• Contribute to the development of the Target Product Profile in collaboration with various line functions.
• Interacts with key stakeholders in multiple departments at all levels.

Qualifications

• BA / BS / University degree required; Life / Health Sciences preferred.
• 2-4 years of Regulatory Affairs and relevant drug/biologic development experience.
• EU/US regulatory experience preferred, including track record of managing submissions.
• Prior experience in managing and submitting INDs, CTAs, BLA, NDAs, MAAs and life cycle management.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate with key stakeholders.
• Knowledge of regulations, guidelines and policy statements.
• Proven ability to consistently deliver within defined timelines, cost, and quality standards.
• Excellent interpersonal skills with the ability to work in a global environment, individually as well as in a multi-disciplinary team, and with external partners and Regulators.
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Knowledge and understanding of applicable regulations.
• RoW regulatory experience is desirable.
• Direct experience of interfacing with relevant regulatory authorities is a plus.
• Experience managing relationships with contractors and CROs also preferred.