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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in US Regulatory Affairs, including drug development and regulatory submissions, while effectively managing compliance and strategic initiatives. Proficient in assessing scientific data and articulating regulatory positions to ensure alignment with FDA regulations.
Highest-signal resume keywords
US Regulatory AffairsRegulatory SubmissionsFDA ComplianceDrug DevelopmentScientific Data Assessment
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 DevelopmentRegulatory Risk IdentificationInvestigational Drug ApplicationsBiologic License ApplicationsAttention to DetailOrganizational SkillsMultitaskingScientific Argument AnalysisNegotiation SkillsRegulatory Lifecycle Maintenance
Soft Skills
Excellent Communication SkillsAbility to Work IndependentlyTeam CollaborationProblem-Solving Skills
Tools & Technologies
MS WordMS ExcelAdobe AcrobatRegulatory Electronic Document Management Systems
Certifications & Qualifications
Accredited Bachelor’s DegreeAdvanced Degree in Science, Chemistry, or Pharmacy (Preferred)
Industry Keywords
Pharmaceutical IndustryBiotech IndustryFDA RegulationsChemistry Manufacturing and ControlsRegulatory Affairs Focus Team
About the role
Key responsibilities & impact- Support creation and implementation of regulatory strategies for assigned drug and biological products
- Participate on global cross-functional teams to ensure US requirements and expectations are achieved compliantly
- Review product documentation for regulatory submissions for accuracy and compliance with FDA regulations
- Manage, review and represent the US regulatory perspective at Regulatory Affairs Focus Team meetings
- Identify regulatory risks, solve problems and offer solutions
- Manage and support FDA submission activities in compliance with regulations and guidance
- Serve as US subject matter expert supporting strategy development and execution
- Act as FDA contact for assigned products and liaise with regulatory authorities
- Manage processing, preparation, review and approval of regulatory submissions
- Monitor the external regulatory climate and inform internal customers of potential impacts
- Lead or assist compliance enhancement and departmental efficiency initiatives
- Assemble and create documentation supporting investigational and new drug applications and biologic license applications throughout the product lifecycle
- Provide high-level regulatory advice and identify US regulatory requirements for clinical studies and marketing
- Assess scientific data for registration and labeling against FDA guidance, regulations and precedents
- Facilitate policy and standard interpretation of US regulations
- Maintain awareness of US regulatory legislation and assess its impact on business and product development programs
- Complete internal and external training on departmental initiatives and compliance
Requirements
What you’ll need- Accredited Bachelor’s Degree
- 7+ years within the pharmaceutical and/or biotech industry
- 5+ years direct experience in US Regulatory Affairs
- Direct experience in US drug development and regulatory submissions supporting investigational and marketing application submissions and lifecycle maintenance activities
- Demonstrated proficiency in following scientific arguments and understanding scientific data and regulations as they relate to drugs and/or biologics
- Experience in identifying regulatory risk and negotiating/resolving differences
- Attention to detail and strong organizational skills with the ability to meet multiple deadlines and multitask within assigned projects
- Demonstrated ability to work in a multi-disciplinary, matrixed and multinational team
- Excellent oral and written communication skills across all levels of the organization, including ability to articulate regulatory positions
- Ability to successfully prepare and execute regulatory strategies along with providing contingencies and alternate approaches
- Ability to work independently
- High proficiency in MS Word, MS Excel, Adobe Acrobat and regulatory electronic document management systems
- Willingness/ability to travel approximately 5% domestically
- If based remotely, additional travel to Boston, MA is required
- Preferred: Accredited Bachelor’s Degree in Science, Chemistry, or Pharmacy
- Preferred: Advanced Degree in Science, Chemistry, Pharmacy or related subject study/experience
- Preferred: Experience in Biologic Development
- Preferred: Familiarity with Chemistry, Manufacturing and Controls requirements
- Strong preference for candidate to be based in Boston, MA area
Benefits
Comp & perks- Eligibility for a 15% bonus target based on company and individual performance
- Eligibility to participate in the company’s long-term incentive plan
- Flexible paid time off (PTO)
- Medical, Dental and Vision health benefits
- Company match 401k
- Reasonable accommodations during the employment application process
- Equal employment opportunity