Home Health Physical Therapist Assistant
BenchMark Physical Therapy
Senior Manager, Regulatory Affairs – Cell and Gene Therapy
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Maryland, Massachusetts, Texas, Wisconsin • 🇺🇸 United States
Visit company websiteSalary
💰 $130,000 - $190,000 per year
Job Level
Senior
About the role
- Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area of cell and gene therapy
- Lead maintenance and improvements to regulatory tools, including regulatory information systems to meet organizational objectives
- Provide regulatory expertise and support to business leadership
- Develop regulatory strategies accounting for global requirements and desired marketing claims
- Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other regulatory bodies
- Provide regulatory direction to product development teams
- Lead all aspects of regulatory compliance of advertising and promotional materials
- Supervise compliance with license registration, listing, and renewal requirements
- Provide leadership and guidance for the reporting and communicating of product-associated complaints, recalls, market withdrawals, and vigilance reports as applicable
- Direct the process for evaluating and processing product change requests including impact assessment
- Propose innovative regulatory options for new products or claims
- Manage departmental budget
- Determine work priorities aligned with business, functional, and company goals
- Lead a team of regulatory professionals
- Communicate a clear plan and motivate the team to achieve goals and defined success metrics
Requirements
- Bachelor’s degree in life sciences, pharmacy, or related field
- Minimum of 8 years related experience in the pharmaceutical or life sciences industry or an advanced degree with 6 years related experience
- 2-4 years of people management experience strongly preferred
- Extensive knowledge of regulatory requirements, including those from the FDA, Health Canada, and other regions
- Ability to evaluate and analyze potential regulatory impact on new and existing products
- Extensive experience in compiling and submitting regulatory filings with a track record of leading successful complex regulatory filings in relation to cell and gene therapies
- Excellent communication skills to effectively interact with internal customers, regulatory authorities, and cross-functional teams
- Advanced organizational and time management skills
Benefits
- Healthcare
- Annual incentive plan bonus
- At least 120 hours paid time off (PTO)
- 10 paid holidays annually
- Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
- Accident and life insurance
- Short- and long-term disability
- Retirement and savings programs, such as competitive 401(k)
- Employees’ Stock Purchase Plan (ESPP)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsregulatory strategiesregulatory complianceregulatory information systemsdevice master filesregulatory support filesimpact assessmentregulatory filingscell and gene therapybudget management
Soft skills
leadershipcommunicationorganizational skillstime managementteam motivationinterpersonal skillsguidanceevaluationanalysisprioritization
Certifications
Bachelor’s degree in life sciencesBachelor’s degree in pharmacyadvanced degree in related field