Sr. Consultant Regulatory Affairs
Lake Forest, Illinois
2rbConsulting is looking to hire a Sr. Consultant Regulatory Affairs for a contract role in Lake Forest, Illinois. Our client is a well-known & respected leader in the Pharmaceutical industry. The individual in this role will be supporting the Life Cycle Management group in remediation and compliance related activities that focus on tech transfers to a new manufacturing site.
- Collaborate with the cross-functional team and support the regulatory team in the completion of different regulatory activities
- Responsible for authoring Module 3 and defining the regulatory strategy
- Weigh impact to regulatory strategy and determine impact assessment of changes related to manufacturing processes and methods
- Responsible for analysis between registration and internal documentation
- Process change controls and work on global regulatory strategies
- Must have at least 5+ years of Regulatory systems and process experience
- Extensive experience with API, drug products, manufacturing processes and validation. Analytical methods and stability are highly preferred
- eCTD and CTD documentation experience
- Strong background with Pharmaceuticals. Pharma experience with Regulatory, R&D, Quality and Operations/Manufacturing is a plus.
- Parental liquid experience is ideal
- Must have excellent written and verbal communication skills
- Bachelor’s Degree
If this opportunity is a good match for your background, skills, and career goals, please submit your resume for immediate consideration! Local candidates highly desired, and candidate must be eligible to work in the US without sponsorship. PLEASE, NO 3rd PARTY CANDIDATES.