Thermo Fisher Scientific Manager, Regulatory Affairs in Florence, South Carolina

Job Description

Job Title: Regulatory Affairs Manager

Requisition ID: 76249BR

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

Florence, SC – API Manufacturing

How will you make an impact?

Under general direction, responsible for successfully filing application submissions and for managing post approval changes requiring regulatory submissions. Can be primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated to successfully file required regulatory documents. Keeps Company informed of significant regulatory issues that affect assigned products/projects.

What will you do?

• Reviews and approves regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the FDA to ensure compliance with applicable regulations and guidance's.

• Uses Structured Product Labeling (SPL) for formatting submissions to FDA

• Performs electronic submissions to FDA using Electronic Submissions Gateway (ESG)

• Interacts with various departments and clients as needed on regulatory issues and/or strategy.

• Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees.

• Review and approve change notices, specifications, batch records, standard test methods, etc. Implements policies to assure on-going compliance of Regulatory Affairs activities.

• Assesses impact of new regulations and suggests appropriate changes to business processes/policies as necessary.

• Interacts with the FDA to facilitate approval of the regulatory submissions

• Ensures sites registrations with FDA and other regulatory industries are maintained up to date.

• Troubleshoots data and resolves problems with technical issues such as test methods and instrumentation.

• Perform other Quality Assurance systems work at discretion of Director of Quality to support Quality Operations, as needed

How will you get here?

Education

• BS –Chemistry or related scientific discipline.

Experience

• 5+ years of regulatory experience and/or quality assurance experience, preferably in the pharmaceutical industry.

Knowledge, Skills, Abilities

• FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations.

• Pertinent Federal and State laws related to pharmaceutical regulatory affairs.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.