Regulatory Affairs Specialist III - Global Submissions
The Role:
As a Regulatory Affairs Specialist III at Thermo Fisher Scientific Inc., you will have the exceptional opportunity to play a crucial role in the planning, managing, and tracking of regulatory submissions and documentation for the production of biological medicines. This is a world-class position where you will collaborate with Regulatory Project Leads to prepare flawless regulatory submissions and ensure their timely delivery to global health authorities. By providing regulatory expertise and acting as the primary point of contact for project teams and health authorities, you will contribute to the successful implementation of regulatory strategies.
Your responsibilities include, but are not limited to:
Accountable for electronically preparing, publishing, quality reviews, validation, dispatch & archiving activities related to global regulatory submissions, including issuing Letters of Authorization to customers.
Collaborate globally with various teams, including regional Regulatory Affairs Managers and a publishing team based in India/USA.
Monitor and motivate project teams, fostering a culture of excellence and ensuring timely and high-quality submissions.
Support the implementation of new technology, tools, and processes, contributing to ongoing initiatives and training, and identifying continuous improvement opportunities.
Coordinate queries and responses to regulatory agencies.
Appropriately handle confidential information.
Manage the development and maintenance of a submission content plan, including tracking document metrics from authoring to approval, publishing, and QC.
Minimum Requirements:
Bachelor's degree in life sciences or a related field.
4+ years of submission-related experience in the life sciences industry, with familiarity in CTD regulatory submission formats and LORENZ submission publishing activities.
Effective interpersonal skills, strong written and oral communication, and presentation skills.
Solid project management, organizational, and time management skills to handle multiple ongoing projects simultaneously.
Familiarity with global Health Authority regulations and submission portals (e.g., CESP, ESG, CTIS). Ability to work independently and with minimal supervision.
Proficiency with computer programs/systems (MS Office, etc.) with a demonstrated ability to learn new systems quickly.
Strong analytical and problem-solving skills. Ability to coordinate and work effectively with cross-functional teams.
Ability to readily adjust to change in a fast-paced environment and multitask.
Thermo Fisher Scientific Inc. is an equal opportunity employer, committed to diversity and inclusion. We provide reasonable accommodations/adjustments to applicants with disabilities to ensure equal access to employment opportunities
Compensation and Benefits
The salary range estimated for this position based in California is $83,300.00 - $125,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
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, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Compensation and Benefits
The salary range estimated for this position based in California is $83,300.00-$115,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
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, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
