For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Director, Regulatory Sciences will be responsible for leading and overseeing projects for US Regulatory science clients, managing a team of professionals, and ensuring the successful delivery of regulatory strategies, submissions, and other deliverables. Expertise in regulatory affairs, pharmaceutical industry knowledge, and leadership skills will be crucial in driving the organization's strategy and achieving business objectives.
Essential Functions
Develop and implement the overall strategy for regulatory submissions, approvals, and maintenance, aligned with the organization's goals and regulatory requirements.
Lead and mentor a team of regulatory professionals, providing guidance, support, and training to ensure high performance and professional development.
Stay updated on relevant regulations, guidelines, and industry trends, ensuring compliance and providing guidance to the team and stakeholders.
Oversee the preparation, review, and timely submission of high-quality client deliverables, including managing interactions with regulatory authorities.
Collaborate with cross-functional teams, including Research and Development, Manufacturing, Quality Assurance, and Legal, to ensure successful regulatory submissions within the defined timelines.
Ensure robust quality oversight for regulatory submissions, ensuring adherence to regulatory requirements and best practices.
Establish and maintain effective relationships with regulatory authorities, consultants, contract research organizations (CROs), and other external partners to support regulatory activities.
Provide input as requested into the department's budget, optimizing resource allocation and ensuring cost-effectiveness.
Identify and mitigate risks associated with deliverables and submissions, proactively addressing challenges and proposing solutions.
Other duties as assigned.
Necessary Skills and Abilities:
Strong leadership skills, with experience managing and developing high-performance teams.
Excellent written and verbal communication skills, with the ability to effectively interact with internal stakeholders, regulatory authorities, and external partners.
Strategic mindset, with the ability to analyze complex regulatory issues and provide innovative solutions.
Strong project management and organizational skills, with the ability to prioritize and manage multiple tasks simultaneously.
Educational Requirements:
Bachelor's degree in a relevant scientific discipline, advance degree preferred.
Experience Requirements:
A minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on regulatory strategic and operational leadership knowledge.
In-depth knowledge of FDA regulations, guidelines, and requirements, including Hatch-Waxman Act and other relevant legislation.
Proven track record of successful regulatory submissions and approvals, with a through understanding of the regulatory processes and requirements.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***