Senior Regulatory Strategy Lead (Global Regulatory Affairs & Clinical Development) | Remote | ProPharma Careers
About ProPharma
ProPharma is a global consulting leader with over 20 years of experience supporting pharmaceutical, biotechnology, and medical device companies. Through its advise-build-operate model, ProPharma delivers integrated solutions across regulatory sciences, clinical research, pharmacovigilance, medical information, and quality & compliance. The organization partners with clients to accelerate development timelines and successfully bring innovative therapies to market.
Job Overview
ProPharma is seeking a Senior Regulatory Strategy Lead to drive global regulatory strategy, scientific leadership, and client advisory across complex drug development programs. This senior-level role involves leading IND, NDA, and BLA strategies, representing clients before global regulatory authorities, and providing high-impact scientific and regulatory guidance across therapeutic areas, including rare diseases, biosimilars, and advanced therapies such as gene therapy.
Job Location & Work Model
Work Type: Remote
Employment Type: Full-time / Senior Leadership Role
Key Responsibilities
Regulatory Strategy and Leadership
Serve as lead regulatory strategist and scientific authority across client engagements
Develop and execute regulatory strategies for IND, NDA, and BLA submissions, including biosimilars and gene therapies
Advise on clinical development plans, study designs, endpoints, and benefit-risk strategies
Lead and manage high-level regulatory authority interactions (FDA, EMA), including Pre-IND, End-of-Phase, and pre-submission meetings
Author, review, and approve key regulatory deliverables such as briefing books, submission modules, and regulatory correspondence
Client and Program Oversight
Lead multidisciplinary teams to design and implement regulatory and clinical strategies
Act as senior reviewer and signatory for critical submission documents
Represent clients in global regulatory meetings as a senior scientific and medical authority
Ensure high-quality, compliant, and timely delivery of consulting outputs
Client Engagement and Advisory Excellence
Serve as a strategic advisor and relationship lead for key client accounts
Translate complex regulatory requirements into actionable development pathways
Provide forward-looking regulatory intelligence based on evolving agency expectations and scientific trends
Deliver high-impact consulting solutions that align with client business and development goals
Internal Leadership and Mentorship
Mentor and develop regulatory scientists, consultants, and project leaders
Lead internal training programs on regulatory strategy, FDA processes, and submission best practices
Promote collaboration across cross-functional consulting teams
Contribute to thought leadership, white papers, and regulatory science publications
Corporate and Business Development Support
Collaborate with Business Development to identify and secure new client engagements
Support proposal development, capability presentations, and scientific advisory discussions
Represent the organization at industry conferences, client meetings, and speaking engagements
Required Skills and Competencies
Deep expertise in global regulatory strategy and clinical development
Strong experience with FDA, EMA, and international regulatory frameworks
Proven ability to lead complex regulatory submissions (IND, NDA, BLA)
Strong scientific and clinical acumen across multiple therapeutic areas
Exceptional leadership, mentoring, and team management capabilities
Strong communication and stakeholder engagement skills at executive level
Strategic thinking with the ability to solve complex regulatory challenges
Experience in rare diseases, biosimilars, or advanced therapies is highly preferred
Educational Qualifications
Advanced degree required (MD, PhD, PharmD, or equivalent in Life Sciences or Medicine)
Experience Requirements
Minimum: 12–15+ years of experience in regulatory affairs, clinical development, or regulatory strategy
Freshers: Not eligible
Required: Extensive experience leading global regulatory submissions and agency interactions
Preferred: Experience in consulting, large pharmaceutical, or biotechnology environments
Why Join ProPharma
Lead high-impact global regulatory strategy initiatives
Work with top-tier pharmaceutical and biotech clients
Influence drug development pathways and regulatory outcomes
Remote flexibility with global exposure
Opportunity to contribute to thought leadership and industry innovation
Diversity, Equity, and Inclusion
ProPharma is committed to fostering a diverse and inclusive workplace where individuals can thrive and contribute meaningfully. The organization values collaboration, innovation, and equal opportunity for all employees.
Application Process
All applications are reviewed by ProPharma’s recruitment team to ensure a fair and transparent hiring process. Candidates receive communication regarding their application status. ProPharma does not use AI-based screening tools.
Important Notice
ProPharma does not accept unsolicited resumes from third-party recruiters. Direct inquiries via phone or email regarding this role are not permitted.
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