To enable our clients to achieve success and enhance human health while inspiring our colleagues to excel! #weinspire
Principal Regulatory Affairs Consultant
Location
United States
Posted
17 days ago
Salary
0
Seniority
Lead
Job Description
Principal Regulatory Affairs Consultant
Syner-G BioPharma Group
• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients. • Handle FDA Type A, Type B, and Type C meetings. • Engage in all phases of drug development, from early-stage to post-registration. • Develop and review regulatory documents, author NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams. • Assist clients with Non-Clinical/Clinical strategy, draft submission documents, and review content for completeness and editorial quality. • Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines. • Lead meetings with FDA representatives, prepare briefing documents, and guide clients through regulatory requirements. • Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement. • Serve as the main point of contact for clients, ensuring effective communication and regulatory support. • Mentor and train new employees in regulatory affairs, Non-Clinical/Clinical, and FDA processes. • Facilitate the development, review, and resolution of comments on technically complex Non-Clinical/Clinical documentation for regulatory submissions. • Partner with clients on Non-Clinical/Clinical strategy and submissions. • Evaluate proposed manufacturing and quality changes for impact on existing registrations. • Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities.
Job Requirements
- Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline; MA degree preferred.
- RAC Certification is a significant advantage; equivalent certifications or extensive experience in regulatory affairs are highly valued.
Benefits
- flexible paid time off
- company-paid holidays
- flexible working hours
- remote work options for most roles
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Compliance EDD, High Risk Client Analyst – Spanish Speaking
BinanceThe World’s Leading Blockchain Ecosystem and Digital Asset Exchange
• Supporting completion of EDD reviews for high risk customers • Assessing high-risk customer transaction activity to ensure it is commensurate with the nature of the business • Conducting risk assessments on new and existing customers • Leading projects related to EDD enhancements • Remain current on global EDD standards such as FATF, as well as local requirements in regions that the company operates • Provide AML/CFT subject matter expertise • Manage high risk customer escalations from the first line of defense and other business units • Drafting of documentation including, but not limited to policies, programs, procedures, guidance documents, training materials, and impact assessment/analysis
Compliance Analyst, EDD/High Risk Client – Japanese Speaking
BinanceThe World’s Leading Blockchain Ecosystem and Digital Asset Exchange
• Supporting completion of EDD reviews for high risk customers • Assessing high-risk customer transaction activity to ensure it is commensurate with the nature of the business • Conducting risk assessments on new and existing customers • Leading projects related to EDD enhancements • Remain current on global EDD standards such as FATF, as well as local requirements in regions that the company operates • Provide AML/CFT subject matter expertise • Manage high risk customer escalations from the first line of defense and other business units • Drafting of documentation including, but not limited to policies, programs, procedures, guidance documents, training materials, and impact assessment/analysis
• Provide compliance advice and guidance to businesses with a franchisee focus. • Work with the senior team to communicate required changes to business practices to meet regulatory requirements. • Develop and maintain strong relationships with franchisees. • Support franchisees with ad-hoc compliance queries. • Review and sign off marketing material for franchisees. • Monitor and ensure regulatory filings are completed on time. • Roll out risk and compliance training to the business. • Support integrating new businesses into the Group.
• Responsible for the coordination, compilation and submission of biologics and medical device applications. • Develop and implement Chemical and Manufacturing Controls (CMC). • Provide guidance to project teams on the regulatory framework from the FDA. • Manage supplier and distributor qualifications and the company’s auditing program. • Maintain voluntary accreditations, state licenses, and establishment registrations.
