Director of Regulatory Affairs

Overview

About us

Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market.

We do this through strategic and complimentary areas of focus : Asset Optimization and Commercialization, Value Access and Outcomes, Medical Strategy and Communications, and Real-World Evidence.

Responsibilities / Position overview

We are seeking a life-sciences professional with deep healthcare / pharma regulatory experience to serve as our Director of Regulatory Affairs.

The Director of Regulatory Affairs is a senior leadership position within our consulting firm, responsible for providing strategic guidance and expert knowledge in the field of regulatory affairs to clients in various industries.

The primary focus of this role is to ensure compliance with applicable laws, regulations, and standards, and to support clients in navigating the complex regulatory landscape.

The Director of Regulatory Affairs will oversee a team of regulatory specialists and collaborate closely with clients, internal teams, and external stakeholders to achieve regulatory compliance and facilitate successful product development and market access.

Responsibilities include :

Regulatory Strategy Development

• Develop and execute comprehensive regulatory strategies for clients, considering their specific business objectives and regulatory requirements.
• Stay abreast of evolving regulatory trends, guidelines, and requirements to provide up-to-date and accurate regulatory advice to clients.
• Collaborate with clients to identify potential regulatory risks, assess their impact, and develop mitigation strategies.

Compliance and Submissions

• Ensure compliance with relevant regulations and standards by conducting thorough reviews and assessments of client products, processes, and documentation.
• Prepare and review regulatory submissions, such as marketing applications, clinical trial applications, labeling, and post-market surveillance reports.
• Liaise with regulatory authorities on behalf of clients, including participating in meetings, responding to inquiries, and resolving regulatory issues.

Regulatory Intelligence and Training

• Monitor changes in the regulatory environment and provide regular updates to clients and internal teams on emerging regulations, guidelines, and industry best practices.
• Conduct training sessions and workshops to educate clients and internal teams on regulatory requirements, processes, and compliance strategies.
• Foster a culture of regulatory awareness within the organization by promoting knowledge-sharing and continuous learning initiatives.

Cross-functional Collaboration

• Collaborate with cross-functional teams, such as product development, quality assurance, clinical affairs, and legal, to ensure regulatory requirements are integrated into business processes.
• Provide guidance and support to clients during interactions with regulatory authorities, including inspections, audits, and product registrations.
• Work closely with business development teams to identify and pursue new regulatory consulting opportunities.

Team Management

• Lead and manage a team of regulatory affairs specialists, providing mentorship, guidance, and professional development opportunities.
• Foster a collaborative and positive work environment, encouraging knowledge-sharing and cross-functional collaboration.
• Conduct performance evaluations, set goals, and provide constructive feedback to team members.

Qualifications

• Bachelor's degree in a relevant scientific discipline. Advanced degree (., Master's or preferred.
• Significant experience in regulatory affairs within the consulting industry or related fields.
• Strong knowledge of national and international regulatory requirements and guidelines (., FDA, EMA, ICH, .
• Demonstrated experience in developing and implementing successful regulatory strategies.
• Proven track record of successful regulatory submissions and interactions with regulatory authorities.
• Excellent project management skills, with the ability to manage multiple projects simultaneously.
• Strong leadership and team management abilities.
• Exceptional communication and presentation skills.
• Ability to adapt to changing regulatory landscapes and proactively identify risks and opportunities.

Benefits

We offer our employees a comprehensive benefits package that focuses on what matters to you health and well-being, personal finances, professional development, and a healthy work / life balance :

• Competitive salary plus bonus scheme
• Medical, dental, and vision insurance options
• 401(k) plan with employer match
• Generous amount of paid time off annually + 10 paid holidays
• Flexible spending accounts for health and dependent care
• Health Savings Account option with employer contribution
• Employee Assistance Program
• Paid short-term and long-term disability coverage
• Company-paid Life Insurance at 1.5x annual base salary and much more

Employees can expect to be paid a salary between $145,000 to $261,000. The salary range is merely an estimate and may vary based on an applicant’s location, skills, prior experience, professional qualifications, and other relevant factors.

Additional compensation may include incentive compensation (. bonus or commission), if applicable. Employee will be also eligible to Lumanity’s benefits, including health care, vision, dental, 401(k), PTO, sick leave and more!

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