Career Opportunities: Global Regulatory Manager (847063)

Work set-up: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 
United States

Offer summary

Qualifications:

Master's degree in Biotechnology, Biochemistry, Biomedical Sciences, or a related field., At least 3 years of experience in regulatory roles within agricultural, biotechnology, or pharmaceutical industries., Experience in preparing and submitting regulatory dossiers and agency submissions., Knowledge of global regulatory processes and legislation related to biotech products..

Key responsibilities:

  • Develop and implement regulatory approval strategies for biotech products.
  • Prepare documentation and dossiers to support product approvals worldwide.
  • Interact with regulatory agencies, including presenting data and negotiating approvals.
  • Support regulatory compliance throughout the product lifecycle.

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Bayer XLarge https://www.bayer.com/
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Job description

 
 

 

Global Regulatory Manager 

 
   
   

Global Regulatory Manager for Chesterfield, MO to obtain & maintain U.S. and global regulatory approvals for biotechnology-derived products; develop & implement regulatory approval strategies, dossiers and agency submissions to achieve optimal regulatory terms for new or existing seeds products; develop & execute safety assessment strategies for new products; provide input on regulatory technical reports; prepare documentation to support U.S. & global product authorizations; track changes to legislation & adapt product strategy to support business objectives; support regulatory compliance throughout product lifecycle. Requires Master’s in Biotechnology, Biochemistry, Biomedical Sciences, or closely-related field & 3 yrs experience in regulatory position(s) in an agricultural, biotechnology, pharmaceutical and/or related science-based industry(ies) working directly with regulatory processes for agricultural, biotechnology, chemistry and/or biologicals products; preparing & submitting regulatory submission packages to regulatory agencies, including dossiers, study reports, data summaries & rationales for approval; responding to requests for information from regulatory agencies; interacting with U.S. and/or global regulatory agencies, including conducting in-person presentations of regulatory data & negotiating and/or advocating for regulatory approvals; developing & implementing regulatory strategies for agricultural, biotechnology, chemistry and/or biologicals product portfolios; managing products cross-functionally; collaborate with global stakeholders to develop regulatory strategies for product approvals; and communicating technical concepts to technical & non-technical audiences. Up to 10% of U.S. and int’l travel req’d. Telecommuting permitted from home office location within reasonable commuting distance of Chesterfield, MO up to 2 days per week. Salary Range: Employees can expect to be paid a salary between $157,000.00 to $170,000.00.  Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. The offered salary may vary within this range based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors. Mail resume to Cascinda Fischbeck, Bayer Research and Development Services LLC, 800 N. Lindbergh Blvd., E2NE, St. Louis, MO 63167 or email resume to careers_us@bayer.com.  Include reference code below with resume.

 

 

Bayer Research & Development Services LLC is an Equal Opportunity Employer/Disabled/Veterans

   

Bayer Research & Development Services LLC is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.  

 
   
If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.  
   
         
Division: Crop Science   Reference Code 847063  
Functional Area: Regulatory   Location: Chesterfield, MO
Employment Type: Regular       
 
 
Contact Us
 
Address Telephone
Creve Coeur, MO  
63167  
                                                                                                                                               OR                         
                                                                                  
                                                                                                careers_us@bayer.com
                                         
 

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
Danish
Check out the description to know which languages are mandatory.

Other Skills

  • Safety Assurance
  • Collaboration
  • Negotiation
  • Data Reporting
  • Presentations
  • Social Skills
  • Communication

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