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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory submissions and strategies within the oncology sector, with strong communication and organizational skills to manage multiple projects effectively.
Highest-signal resume keywords
Regulatory SubmissionsOncology Product ExperienceDrug DevelopmentRegulatory Agency InteractionScientific And Analytical Skills
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 Strategy DevelopmentMarketing ApplicationsIND ApplicationsPediatric PlansRegulatory Agency RequestsQuality ComplianceLifecycle ManagementLabel DevelopmentProcess ImprovementRegulatory Administrative Activities
Soft Skills
Excellent Oral CommunicationExcellent Written CommunicationGood Organizational SkillsFlexibilityAttention To Detail
Industry Keywords
Pharmaceutical IndustryRegulatory GuidelinesGlobal Regulatory TeamsCross-Functional MeetingsClinical ResearchNon-Clinical SafetyRegulatory OperationsCompetitive IntelligenceAgency MeetingsUS And Puerto Rico Residency Eligibility
About the role
Key responsibilities & impact- Support oncology products as part of a regulatory team
- Work with global regulatory leads to develop and implement global registration and product-maintenance strategies
- Assist with regulatory submissions, including marketing applications, IND applications, pediatric plans, and annual or periodic reports
- Track, author, shepherd, and/or review responses to regulatory agency requests
- Develop agency background packages and documents for marketing applications
- Communicate with agencies and attend agency meetings as needed
- Participate in global regulatory teams and cross-functional meetings
- Research and review regulatory guidelines, precedents, and competitive intelligence
- Assist in authoring regulatory strategy documents
- Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, clinical research, and non-clinical safety teams
- Support quality compliance and lifecycle management of oncology programs
- Support label development
- Assist with process improvement initiatives
- Perform regulatory administrative activities as needed
Requirements
What you’ll need- Bachelor’s Degree with at least 5 years of relevant experience in the pharmaceutical industry; or Master’s Degree with at least 2 years of relevant experience in the pharmaceutical industry; or M.D., Ph.D., or other related doctoral degree in biological science, chemistry, or related discipline with relevant experience
- Experience in drug development
- Prior regulatory experience interacting with a major regulatory agency
- Excellent oral and written communication skills
- Good organizational skills with proven ability to balance diverse activities for multiple projects simultaneously
- Flexibility
- Strong scientific and analytical skills with attention to detail
- Oncology product experience highly preferred
- US and Puerto Rico residency eligibility
- No visa sponsorship available
- Up to 10% travel
- Valid driving license not required
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Hybrid work arrangement