Sr. Manager, Regulatory Affairs

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information
St Louis, MO  (Remote) / Pharma Services  

How will you make an impact?

Plan, oversee, and provide Regulatory Services activities supporting regulatory aspects of customer projects in accordance with the Regulatory Services menu. Execute activities and collaborates to assure the company/site compliance with applicable regulations including establishment registration, drug listing, drug master files and site master files. Support project quote development.
 
What will you do?
 
• Author, review and provide comments for biologics Chemistry Manufacturing and Control (CMC) CTD documents, including Investigational Applications (IND, CTX), Marketing Applications (NDA, NDS, MAA, BLA), and post-approval lifecycle dossiers, gap analyses and responses to review questions per the North American Regulatory Affairs Services Menu
• Collaborate and coordinate within NA RA and with SMEs to support the authoring and review activities of CMC CTD documents
• Participate, as appropriate, in preparation of company regulatory submissions (e.g. site master files, drug master files)
• Support key company projects in the North America region such as new facilities, new strategic customers
• Draft biologics regulatory strategic advice for internal customers and for clients
• Support quote development for regulatory services
• Contribute to the maintenance of centralized records for compliance status of North American manufacturing sites
• Perform regulatory impact evaluation of change controls
• Track and reporting out NA Regulatory Services metrics for North American network
• Contribute to regulatory intelligence surveillance and communication to the network
 
How you will get here?
Education
 
Bachelor’s degree in a biological sciences field is required
 
Required Experience:
 
7-8 years regulatory CMC experience in the pharmaceutical industry specializing in biologics
 

 Knowledge, Skills, Abilities

• Experienced regulatory professional in the area of regulatory CMC for biological drugs
• Mature, results-oriented self-starter who can execute roles and responsibilities with minimal    supervision
• Ability to motivate and influence without line-management authority
• Strong knowledge of regional regulatory requirements and the global regulatory environment
• Advanced ability to evaluate and resolve complex regulatory and technical issues due to extensive knowledge of biological manufacturing and related regulatory requirements
• Advanced organizational skills, with ability to multi-task in a fast-paced environment.
• Excellent attention to technical detail
• Highly effective verbal and written communication skills
• Sound skills in typical office electronic platforms
• Advanced negotiation and influencing skills with internal stakeholders, clients and regulatory bodies
• Collaborative team player with strong interpersonal skills who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, internal and external
• Ability to demonstrate discretion, confidentiality and independent judgement
• Highly effective time management and prioritization skills
  
At Thermo Fisher Scientific, each one of our 75,000 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.