Regulatory Affairs & Quality Process Manager
Sirona Medical
US Regulatory Lead
Amgen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $112,345 - $143,224 per year
Job Level
Senior
About the role
- Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission)
- Act as the point of contact with regulatory agencies
- Provide guidance on local mechanisms to optimize product development and regulatory approvals
- Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements
- Ensure and support local regulatory product compliance (eg, agency commitments)
- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures
- Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Plans, labeling documents, etc.
- Assist the GRL by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions
- Provide primary authorship to routine regulatory correspondence
Requirements
- Doctorate degree OR Master’s degree and 3 years of regulatory or drug development experience OR Bachelor’s degree and 8 years of industry experience OR Associates degree and 10 years of Regulatory Affairs experience OR High school diploma / GED and 12 years of relevant experience
- Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
- Regulated industry, science or clinical practice experience
- Organizational skills - detail oriented and can deal with frequent changes in product activity
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
IND developmentregulatory submissionsregulatory complianceregulatory strategylabeling documentsregulatory correspondenceregulatory landscapesproduct developmentregulatory approvalssupportive documentation
Soft skills
organizational skillsdetail orientedadaptability
Certifications
Doctorate degreeMaster’s degreeBachelor’s degreeAssociates degreeHigh school diploma / GED
