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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in Regulatory Affairs with a focus on developing and executing regulatory strategies for clinical development and life-cycle management. Proven ability to lead regulatory submissions and interactions with global health authorities while ensuring compliance with regulatory requirements.
Highest-signal resume keywords
Regulatory Affairs LeadershipRegulatory Submission ExperienceNegotiation Skills with Health AuthoritiesRegulatory Strategy DevelopmentCross-Functional Team Representation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Submission DevelopmentIND SubmissionNDA SubmissionCTx SubmissionRegulatory Strategy ExecutionRisk-Mitigation Strategy DevelopmentRegulatory ComplianceHealth-Authority ReportingRegulatory Policies DevelopmentAI Implementation for Regulatory Dossiers
Soft Skills
Strong Negotiation SkillsExcellent Oral CommunicationExcellent Written CommunicationExcellent Presentation SkillsOrganizational Awareness
Industry Keywords
PharmaBiotechFDAEMAHealth CanadaClinical DevelopmentLife-Cycle ManagementRegulatory Operational ActivitiesSOP DevelopmentProject Management
About the role
Key responsibilities & impact- Provide regulatory leadership for Enveda's assets through Phase 2 and beyond
- Develop innovative global regulatory strategies for Enveda's clinical-development and life-cycle-management portfolio
- Lead development of regulatory submissions, including INDs, CTx, briefing documents, IB, NDA, DMF, and IMPD
- Identify submission gaps and develop risk-mitigation strategies
- Represent Enveda with global health authorities and lead agency interactions
- Represent Regulatory Affairs on cross-functional teams as the subject matter expert
- Provide regulatory guidance and oversight to global project teams
- Ensure regulatory activities comply with health-authority requirements
- Coordinate and maintain health-authority reporting schedules
- Monitor the regulatory landscape and inform leadership of health-authority initiatives and impacts
- Lead, mentor, and develop global regulatory teams
- Develop Regulatory Affairs policies, SOPs, and work instructions
- Guide cross-functional teams on AI implementation for regulatory dossiers
Requirements
What you’ll need- Bachelor's degree in a scientific discipline
- At least 12 years of Regulatory Affairs experience in pharma or biotech
- Strong negotiation skills with health authorities, including FDA, EMA, and Health Canada
- Submission experience from IND/CTx through NDA or marketing applications
- Experience developing and executing regulatory strategies for oral small-molecule programs
- Excellent oral, written, and presentation skills, including experience presenting to leadership teams
- Demonstrated organizational awareness and cross-functional representation experience
- Excellent planning and organizational skills, with ability to manage multiple projects with tight timelines
- Strong understanding of regulatory operational activities
- Self-starter with an entrepreneurial spirit, flexible and proactive in adapting to changing business needs and priorities
- Pragmatic, compliant, solution-oriented mindset
Benefits
Comp & perks- Equal opportunity employer
- Diversity-valuing workplace