Director, Regulatory Sciences – United States
Job ID: JR 8849
Location: United States
Employment Type: Full-time
Functional Area: Regulatory Affairs | Pharmaceutical | Life Sciences
Work Mode: Hybrid / Remote (as applicable)
About ProPharma
For over 20 years, ProPharma has empowered pharmaceutical, biotechnology, and medical device companies worldwide to advance scientific innovations and bring new therapies to market. Through its advise–build–operate model, ProPharma delivers end-to-end solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology. Our global expertise supports clients in accelerating high-profile drug and device programs with precision, compliance, and innovation.
Role Overview
The Director, Regulatory Sciences will lead and oversee US regulatory affairs projects, guiding a team of professionals to ensure successful regulatory strategy execution, submissions, and approvals. This senior leadership position requires deep knowledge of regulatory processes, FDA regulations, and pharmaceutical development, along with strong project management and team leadership skills.
The ideal candidate will be a strategic thinker, capable of driving regulatory compliance, fostering cross-functional collaboration, and mentoring high-performance teams to deliver world-class regulatory solutions.
Key Responsibilities
Develop and implement comprehensive regulatory strategies for US submissions, approvals, and ongoing compliance aligned with business objectives.
Lead, mentor, and manage a team of regulatory professionals, fostering career development, performance excellence, and professional growth.
Ensure timely preparation, review, and submission of high-quality regulatory documents, including managing communications with FDA and other regulatory authorities.
Collaborate closely with R&D, Manufacturing, Quality Assurance, and Legal teams to align regulatory deliverables with project timelines and operational goals.
Maintain up-to-date knowledge of FDA regulations, guidelines, and relevant legislation (including Hatch-Waxman Act), providing guidance to internal teams and external partners.
Establish and manage relationships with regulatory authorities, consultants, contract research organizations (CROs), and other external stakeholders to support regulatory activities.
Oversee quality control and compliance for all regulatory submissions, ensuring adherence to best practices and regulatory requirements.
Identify potential risks and challenges associated with submissions and implement proactive solutions to mitigate them.
Contribute to departmental resource planning and budget allocation to optimize efficiency and cost-effectiveness.
Perform other duties as assigned to support organizational regulatory objectives.
Required Qualifications
Education:
Bachelor’s degree in Life Sciences, Pharmacy, or related field (Advanced degree preferred).
Experience:
Minimum of 7 years in regulatory affairs within the pharmaceutical or biotech industry.
Proven experience leading regulatory strategy, operational delivery, and US FDA submissions.
Strong familiarity with FDA regulations, guidance documents, and legislative frameworks relevant to pharmaceuticals.
Demonstrated track record of successful regulatory submissions and approvals.
Skills & Competencies:
Exceptional leadership, mentoring, and team management capabilities.
Excellent written and verbal communication, capable of engaging internal stakeholders, FDA representatives, and external partners.
Strategic mindset with strong analytical and problem-solving skills.
Advanced project management and organizational skills to handle multiple high-priority projects simultaneously.
Ability to operate in a fast-paced, multidisciplinary, and regulated environment.
Diversity & Inclusion
ProPharma is committed to fostering an inclusive workplace where employees are empowered to be their authentic selves. We encourage collaboration, innovation, and entrepreneurial thinking, and we provide equal opportunities for all employees to succeed.
Recruitment & Work Model
All applications are reviewed personally by ProPharma’s recruitment team—AI screening is not used. Candidates will receive feedback on their applications. While remote work is supported, candidates located near offices may be asked to follow a hybrid schedule to facilitate collaboration.
Apply now to join a global leader in regulatory sciences and drive impactful solutions that shape the future of healthcare.
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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