The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure adherence to regional regulations. Close collaboration with the cross-functional Development team, external consultants, and advisors is essential to seamlessly integrate regulatory plans and strategies in alignment with overall corporate objectives.
Responsibilities:
Represent the Regulatory Affairs department in multidisciplinary product development teams
Develop and execute global regulatory strategies for expedited product development across one or more programs
Lead preparation of global product development plans, target product profiles, orphan drug designation applications, and pediatric study plans
Research regulatory precedents and emerging trends for development risks and opportunities
Oversee the global regulatory lifecycle of assigned investigational products, managing timelines and coordinating submission content
Interface with the external Regulatory Operations group for document compilation and e-submission
Serve as the primary liaison for communication with regulatory health authorities
Lead milestone development meetings and prepare the team for engagements
Review and communicate current regulatory requirements for compliance with US and international regulations
Contribute to the development and review of standard operating procedures (SOPs)
Assist in archival and maintenance of regulatory application submissions
Monitor the company's progress in meeting regulatory commitments
Requirements:
Bachelor's degree in life sciences; advanced degree preferred; Regulatory Affairs Certification a plus
Strong pharmaceutical Regulatory Affairs experience with a focus on drug/biologics development
Direct experience in preparing, submitting, and managing global investigational/marketing applications in eCTD format
Experience negotiating and interfacing with US and international regulatory authorities
Product development experience in dermatology, immunology, or inflammation is a plus
In-depth knowledge of GXP/ICH guidelines and global regulations
Ability to interpret and apply complex regulatory guidance
Strong written and verbal communication, analytical, organizational, and interpersonal skills
Excellent strategic planning and cross-functional project management skills
Ability to thrive in a dynamic environment with flexibility