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Regulatory Manager
Syneos Health. Research existing product data against global or regional regulatory requirements .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in regulatory affairs, including preparation of regulatory submissions and compliance with global requirements. Possesses strong leadership skills and the ability to manage multidisciplinary teams throughout the product life cycle.
Highest-signal resume keywords
Regulatory Affairs ExperienceTeam LeadershipRegulatory Submissions (IND, PMA, NDA, MAA, CTD)CMC Module 3 ExpertiseFluency in English
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 SubmissionsGap AnalysisRisk AssessmentProject LeadershipCMC Section AuthoringQuality ManagementSOP CreationRegulatory ComplianceProduct Development PlansRegulatory Agency Interactions
Soft Skills
Excellent Communication SkillsCustomer Service SkillsAnalytical SkillsAdaptabilityProactivity
Tools & Technologies
Microsoft Office
Certifications & Qualifications
M. Pharm DegreeMaster's Degree in Science-Related Field
Industry Keywords
EU Market ExperienceGCC Market ExperiencePharmaceutical ExperienceMedical Device ExperienceProject Audits
About the role
Key responsibilities & impact- Research existing product data against global or regional regulatory requirements
- Prepare gap analyses, product development plans, and regulatory submissions
- Prepare administrative and technical components of submissions for INDs, pre-approval packages, product registrations, and post-approval maintenance
- Prepare briefing packages for regulatory agency meetings or scientific advice
- Contribute to and support regulatory agency interactions
- Manage and operationalize day-to-day regulatory activities within timelines, scope, budgets, and strategies
- Provide regulatory support on multidisciplinary product development teams throughout the product life cycle
- Act as a subject matter expert and troubleshoot project-related issues
- Prepare estimates for regulatory services in proposals
- Support client meetings concerning proposals, project status, and business development
- Ensure compliance with global regulatory requirements and company policies and processes
- Prepare training materials and share regulatory best practices internally and externally
- Participate in internal and external project audits
- Support internal cross-functional initiatives
- Create and maintain SOPs and process documentation
- Provide oversight support to team members executing project responsibilities
- Identify when additional line support is needed
- Maintain individual training records and complete required training
Requirements
What you’ll need- Minimum 10+ years of experience in regulatory affairs
- Functional lead experience leading a team
- Risk assessment capability, strategic thinking, decision-making, and project leadership
- Experience handling internal and external stakeholders
- M. Pharm degree
- Experience with CMC Module 3
- Experience authoring CMC sections of post-approval variations and life cycle management activities
- EU and GCC market experience
- Master's degree, preferably in a science-related field, or equivalent experience in a science/regulatory/medical writing-related field
- Moderate pharmaceutical/medical device-related experience
- Experience contributing to regulatory submissions such as IND, PMA, NDA, MAA, and CTD, including electronic submissions
- Excellent written and verbal communication skills
- Excellent customer service skills and ability to work independently and as part of a team
- Good quality management skills
- Advanced Microsoft Office skills
- Ability to interact with staff from multiple departments and offices to establish project standards
- Initiative, adaptability, and proactivity
- Strong analytical skills and attention to detail
- Ability to work concurrently on multiple projects with differing instructions
- Fluency in spoken, written, and read English
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate