Job description
Job Title: Senior Director of Regulatory Affairs
Our client is entering clinical trials and actively seeking a seasoned and highly skilled Senior Director of Regulatory Affairs. This pivotal role is at the heart of our client's operations. This will be a highly visible role, supporting a pivotal Ph II study and IND filing in the immediate term, as well as helping to build a regulatory department. This is a platform company so is pursuing various therapeutic areas inclusive of Oncology and Neuroscience. They are seeking a strong regulatory strategist with global regulatory experience.
Principal Responsibilities:
• Formulate and execute comprehensive regulatory strategies for both new and existing products, ensuring alignment with overall business objectives.
• Spearhead interactions with regulatory authorities, fostering strong relationships to facilitate timely product approvals and maintain open lines of communication.
• Supervise the meticulous preparation and submission of regulatory documents, ensuring accuracy, completeness, and compliance with all relevant guidelines.
• Guarantee strict compliance with all relevant regulations and standards, implementing robust systems and processes to monitor and ensure adherence.
• Provide expert regulatory guidance to cross•functional teams, fostering a culture of regulatory compliance across the organization.
Candidate Profile:
• Demonstrable experience in a similar leadership role within the regulatory affairs sector, with a proven track record of success.
• In•depth knowledge of regulatory requirements and procedures, with the ability to interpret and apply this knowledge to diverse situations.
• Exceptional leadership and team management skills, with the ability to inspire and motivate teams to achieve excellence.
• Superior communication and negotiation skills, with the ability to effectively articulate complex regulatory concepts and negotiate favorable outcomes.
• Ability to thrive in a fast•paced environment, effectively managing multiple projects and priorities.
This is an exceptional opportunity to join our client's team and play a pivotal role in their ongoing success. The successful candidate will have the opportunity to significantly influence the company's regulatory strategy and contribute to their mission. If you are a strategic thinker with a passion for regulatory affairs and a drive to achieve excellence, we invite you to apply.
Our client is entering clinical trials and actively seeking a seasoned and highly skilled Senior Director of Regulatory Affairs. This pivotal role is at the heart of our client's operations. This will be a highly visible role, supporting a pivotal Ph II study and IND filing in the immediate term, as well as helping to build a regulatory department. This is a platform company so is pursuing various therapeutic areas inclusive of Oncology and Neuroscience. They are seeking a strong regulatory strategist with global regulatory experience.
Principal Responsibilities:
• Formulate and execute comprehensive regulatory strategies for both new and existing products, ensuring alignment with overall business objectives.
• Spearhead interactions with regulatory authorities, fostering strong relationships to facilitate timely product approvals and maintain open lines of communication.
• Supervise the meticulous preparation and submission of regulatory documents, ensuring accuracy, completeness, and compliance with all relevant guidelines.
• Guarantee strict compliance with all relevant regulations and standards, implementing robust systems and processes to monitor and ensure adherence.
• Provide expert regulatory guidance to cross•functional teams, fostering a culture of regulatory compliance across the organization.
Candidate Profile:
• Demonstrable experience in a similar leadership role within the regulatory affairs sector, with a proven track record of success.
• In•depth knowledge of regulatory requirements and procedures, with the ability to interpret and apply this knowledge to diverse situations.
• Exceptional leadership and team management skills, with the ability to inspire and motivate teams to achieve excellence.
• Superior communication and negotiation skills, with the ability to effectively articulate complex regulatory concepts and negotiate favorable outcomes.
• Ability to thrive in a fast•paced environment, effectively managing multiple projects and priorities.
This is an exceptional opportunity to join our client's team and play a pivotal role in their ongoing success. The successful candidate will have the opportunity to significantly influence the company's regulatory strategy and contribute to their mission. If you are a strategic thinker with a passion for regulatory affairs and a drive to achieve excellence, we invite you to apply.