Director, Regulatory Affairs in United States at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Regulatory Affairs in United States.
This senior regulatory leadership role offers the opportunity to shape global regulatory strategy for innovative ophthalmology drug and combination product programs across all stages of development and commercialization. You will play a critical role in guiding products from early development through global approvals and market expansion, ensuring alignment with complex international regulatory requirements. Acting as a key partner to cross-functional teams, you will influence clinical, nonclinical, CMC, quality, and safety strategies while driving regulatory excellence and risk mitigation. The role involves direct engagement with health authorities and leadership of high-impact regulatory submissions and interactions. You will also contribute to the development of global regulatory frameworks and mentor regulatory professionals within a highly collaborative, science-driven environment. This position is ideal for a strategic regulatory expert who thrives in global, fast-paced, and highly regulated life sciences environments.
- Define and execute global regulatory strategies for ophthalmology drug and combination product programs across all development phases, ensuring alignment with clinical, CMC, and commercial objectives.
- Lead regulatory interactions with health authorities, including preparation and management of meetings such as pre-IND, end-of-phase, and pre-NDA/BLA discussions.
- Oversee the development, preparation, and submission of high-quality global regulatory filings supporting product approvals and lifecycle management.
- Interpret global regulatory policies and guidance and apply them effectively to product development, labeling, and submission strategies.
- Drive innovative regulatory approaches to increase the likelihood of approval and optimize development pathways.
- Provide regulatory leadership and strategic input across cross-functional teams including Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory Operations.
- Mentor and develop regulatory team members, including individual contributors and matrixed team structures.
- Contribute to regulatory budgeting and resource planning activities.
- Monitor regulatory intelligence and emerging global requirements to inform strategic decision-making.
Requirements:
- Bachelor’s degree required; advanced degree (Master’s, PhD, PharmD) strongly preferred.
- 10–15+ years of experience in Regulatory Affairs or other regulated life sciences environments.
- Strong experience in global regulatory strategy and submissions, particularly within ophthalmology, drug development, or combination products.
- Deep knowledge of regulatory authority processes, policies, and global submission requirements, including ex-U.S. regions.
- Proven ability to lead health authority interactions and manage complex regulatory relationships.
- Strong scientific and analytical capabilities to evaluate data, risk, and technical arguments with precision.
- Demonstrated strategic mindset with strong business acumen and ability to influence development and commercialization decisions.
- Experience leading, coaching, and mentoring regulatory teams in matrixed or global environments.
- Excellent written and verbal communication skills with strong attention to detail and documentation quality.
- Ability to manage multiple priorities, work independently, and deliver under tight timelines in a dynamic environment.
- Strong interpersonal and influencing skills to engage internal stakeholders and external regulatory bodies.
- RAPS certification is preferred.
Benefits:
- Competitive compensation package with base salary ranging from $165,000 to $220,000 depending on experience.
- Eligibility for short-term and long-term incentive programs.
- Comprehensive healthcare coverage including medical, dental, vision, disability, and life insurance from day one.
- 401(k) retirement plan with company match and ongoing contributions.
- Paid time off including 3 weeks of vacation (prorated), floating holidays, and sick leave.
- Employee stock purchase plan with company match.
- Tuition reimbursement for select degree programs.
- Annual performance and compensation reviews.
- Additional wellness, insurance, and employee benefit programs.