Director, Regulatory Affairs
Scorpion Therapeutics, Waltham, Massachusetts, United States, 02254
Role Summary
Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. The Director, Regulatory Affairs will be responsible for the strategic leadership, development and execution of science-based, solution-oriented, and globally aligned regulatory strategies for the program(s) under his/her accountability. This role serves as a key regulatory leader and decision maker, influencing program direction and regulatory positioning across regions. Responsibilities
Ensure alignment of global regulatory strategies with Apellis corporate objectives. Lead and influence cross-functional discussions to ensure the global regulatory strategy is incorporated and implemented within the stakeholder deliverables throughout development and commercialization. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to serve as the primary regulatory strategic advisor, strategically interpret, plan, and communicate requirements to strategy teams. Communicate to regulatory team, cross-functional teams, and senior leaders clear regulatory risks, options, trade-offs, and immediate to long-range plans to carry out established objectives. Provide global regulatory leadership and strategic perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s), including clinical protocols, annual reports, clinical trial applications (CTA) / IND amendments, marketing applications, and post-approval change documents. Lead the development of global regulatory strategy plans and the content of global regulatory dossiers. Oversee and be accountable for regulatory agency submissions and approvals, with a quality focus to secure first-cycle approvals. Ensure compliance with global regulatory requirements. Drive resolution of regional conflicts in global regulatory strategies and oversee critical deliverables to all territories. Represent the company as the regulatory lead at key regulatory agency meetings; lead, moderate, and negotiate discussions with health authorities. Develop and maintain trusted productive relationships with regulatory agency personnel, regulatory experts, and consultants to optimize regulatory outcomes and proactively shape regulatory pathways. Proactively anticipate, assess, and mitigate regulatory risks. Demonstrate critical thinking, leadership, and project management accountability in close collaboration with strategy teams. Under minimal guidance of supervisor, provide clear, actionable regulatory assessments and recommendations to teams and senior leadership. Research and analyze regulatory information; maintain current regulatory knowledge to keep abreast of regulatory procedures, changes, and trends. Assess the impact of evolving global regulatory landscapes on assigned programs and provide relevant guidance and expertise to project/program teams. Demonstrate strong understanding of US FDA, EU EMA, and international guidance, regulations, drug development process, and leadership behaviors consistent with a Director level role including strategic thinking, cross-functional influence, and mentorship as appropriate. May provide functional or matrix leadership, mentorship, and regulatory oversight to other Regulatory Affairs team members or project team members. Qualifications
Required: At least 10 years of progressive regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development, with US and international regulatory experience. Required: Demonstrated experience leading global regulatory strategies and major health authority interactions. Preferred: Ophthalmology experience. Education
B.S. or graduate degree in life sciences Regulatory Affairs Certification preferred Additional Requirements
Travel Requirements: None
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Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. The Director, Regulatory Affairs will be responsible for the strategic leadership, development and execution of science-based, solution-oriented, and globally aligned regulatory strategies for the program(s) under his/her accountability. This role serves as a key regulatory leader and decision maker, influencing program direction and regulatory positioning across regions. Responsibilities
Ensure alignment of global regulatory strategies with Apellis corporate objectives. Lead and influence cross-functional discussions to ensure the global regulatory strategy is incorporated and implemented within the stakeholder deliverables throughout development and commercialization. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to serve as the primary regulatory strategic advisor, strategically interpret, plan, and communicate requirements to strategy teams. Communicate to regulatory team, cross-functional teams, and senior leaders clear regulatory risks, options, trade-offs, and immediate to long-range plans to carry out established objectives. Provide global regulatory leadership and strategic perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s), including clinical protocols, annual reports, clinical trial applications (CTA) / IND amendments, marketing applications, and post-approval change documents. Lead the development of global regulatory strategy plans and the content of global regulatory dossiers. Oversee and be accountable for regulatory agency submissions and approvals, with a quality focus to secure first-cycle approvals. Ensure compliance with global regulatory requirements. Drive resolution of regional conflicts in global regulatory strategies and oversee critical deliverables to all territories. Represent the company as the regulatory lead at key regulatory agency meetings; lead, moderate, and negotiate discussions with health authorities. Develop and maintain trusted productive relationships with regulatory agency personnel, regulatory experts, and consultants to optimize regulatory outcomes and proactively shape regulatory pathways. Proactively anticipate, assess, and mitigate regulatory risks. Demonstrate critical thinking, leadership, and project management accountability in close collaboration with strategy teams. Under minimal guidance of supervisor, provide clear, actionable regulatory assessments and recommendations to teams and senior leadership. Research and analyze regulatory information; maintain current regulatory knowledge to keep abreast of regulatory procedures, changes, and trends. Assess the impact of evolving global regulatory landscapes on assigned programs and provide relevant guidance and expertise to project/program teams. Demonstrate strong understanding of US FDA, EU EMA, and international guidance, regulations, drug development process, and leadership behaviors consistent with a Director level role including strategic thinking, cross-functional influence, and mentorship as appropriate. May provide functional or matrix leadership, mentorship, and regulatory oversight to other Regulatory Affairs team members or project team members. Qualifications
Required: At least 10 years of progressive regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development, with US and international regulatory experience. Required: Demonstrated experience leading global regulatory strategies and major health authority interactions. Preferred: Ophthalmology experience. Education
B.S. or graduate degree in life sciences Regulatory Affairs Certification preferred Additional Requirements
Travel Requirements: None
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