Regulatory Affairs Leader (Director, Senior Director, VP)

My client, a leading life sciences consulting firm, is searching for an experienced Regulatory Affairs Leader to serve as a strategic regulatory advisor to our clients in the fields of oncology and rare diseases. This is an exciting opportunity to work with innovative companies focused on developing complex therapeutics.

Here is a job advert based on the information provided:

Regulatory Affairs Leader (Director, Senior Director, VP)

My client, a leading life sciences consulting firm, is searching for an experienced Regulatory Affairs Leader to serve as a strategic regulatory advisor to our clients in the fields of oncology and rare diseases. This is an exciting opportunity to work with innovative companies focused on developing complex therapeutics.

Responsibilities:

• Provide expert regulatory guidance and strategic advice to clients on developing robust regulatory roadmaps for successful product development and commercialization
• Actively participate in business development efforts, including proposal writing, client presentations, and new business opportunities
• Build and maintain strong relationships with clients, understanding their unique regulatory challenges and partnering to develop tailored solutions
• Stay up-to-date on the latest regulatory guidelines, policies, and best practices in your areas of expertise
• Lead and mentor a team of regulatory affairs professionals to ensure high-quality deliverables and exceptional client service
• Collaborate cross-functionally with other practice areas, such as clinical, CMC, and market access, to deliver comprehensive solutions
• Contribute to the firm’s thought leadership through the development of white papers, webinars, and conference presentations

Requirements

Requirements:

• Advanced degree in a life sciences discipline (e.g., pharmacy, medicine, regulatory affairs, or a related field)
• 10+ years of regulatory affairs experience, preferably in the oncology and/or rare disease therapeutic areas
• Demonstrated success in leading complex regulatory strategy development and successful regulatory submissions
• Proven track record of active involvement in business development activities, including proposal writing, client presentations, and new business acquisition
• Strong commercial mindset with the ability to understand client needs and translate them into practical regulatory solutions
• Excellent communication and interpersonal skills, with the ability to effectively present and influence at all levels of an organization
• Familiarity with international regulatory frameworks and guidelines (e.g., FDA, EMA, PMDA)
• Experience managing and mentoring a team of regulatory affairs professionals
• Willingness to travel as needed to support client engagements

If you are an ambitious and strategically-minded Regulatory Affairs Leader who is passionate about delivering innovative solutions to our clients, we encourage you to apply.