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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing study start-up and regulatory strategies, managing complex projects, and ensuring compliance with regulatory requirements. Proven ability to lead teams, negotiate agreements, and contribute to business development efforts.
Highest-signal resume keywords
Study Start-Up ManagementRegulatory Affairs ExpertiseProject ManagementRisk Assessment and MitigationClient Relationship Building
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 Requirements KnowledgeProject Budget ManagementStudy Start-Up Document TrackingClinical Site Agreement NegotiationProposal Development
Soft Skills
Coaching and MentoringPerformance FeedbackCommunication Skills
Industry Keywords
Pharmaceutical IndustryCRO IndustryLife SciencesClinical ResearchGlobal Project Management
About the role
Key responsibilities & impact- Develop study start-up and regulatory strategies based on regulatory requirements
- Coordinate and oversee all study start-up deliverables from site selection through site initiation readiness
- Lead study start-up and regulatory activities for assigned medium- to high-complexity projects
- Manage end-to-end delivery of study start-up and regulatory milestones
- Collect, review, and track essential study start-up documents
- Investigate incomplete, inaccurate, or missing documents
- Prepare study team reports and status updates
- Negotiate and execute clinical site agreements, ancillary agreements, and amendments
- Identify, assess, and mitigate risks affecting timelines
- Build relationships with clients, regulatory authorities, and internal stakeholders
- Monitor project budgets and hours against budget; escalate out-of-scope work
- Support business development meetings, proposals, regulatory costing, and budgets
- Provide strategic input into bids and contribute to winning new business
- Coach, guide, mentor, and provide performance feedback to junior team members
- Potentially line-manage staff
- Perform other work-related duties as assigned
Requirements
What you’ll need- Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience
- 6–8 years within the pharmaceutical or CRO industry or a regulatory body
- At least 3 years in a leading/project management role
- Proven ability to successfully manage global projects
- Experience with study start-up and regulatory affairs
- Knowledge of regulatory requirements and country regulations
- Ability to manage projects of medium to high complexity
- Ability to develop regulatory strategies and contribute to proposals, costing, and budgets
- Ability to manage timelines, quality standards, project budgets, and regulatory milestones
Benefits
Comp & perks- Collaborative, international team
- Career growth opportunities
- Flexible work environment
- Work-life balance
- Coaching, guidance, and performance feedback to support development
- Opportunity to contribute to meaningful work helping bring safe and effective pharmaceutical treatments to patients
- Supportive, inclusive workplace where every voice counts