Regulatory Affairs Specialist
Source One Technical Solutions Fort Worth, TX
- Expired: over a month ago. Applications are no longer accepted.
Seeking a Regulatory Affairs Specialist for a consulting position at a pharmaceutical client in Fort Worth, TX 76134.
This position will independently provide tactical and strategic leadership on complex CMC projects within the Global Regulatory Affairs organization by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of pharmaceuticals/devices.
- Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms.
- Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
- Guide and influence technical groups in areas of product lifecycle management and enhancement.
- Support the negotiating and decision making with regulators and stakeholders with complex and high-risk projects.
- Experience in a pharmaceutical manufacturing facility/development laboratory preferred.
- Develop and implement regulatory strategy aligned with business strategy.
- Assess impact of new regulations and implement appropriate changes
- Support the Initiation and maintenance of appropriate communication within the RA function and stakeholders
- Participate in Due Diligence activities
- Interpret, apply and implement global regulations to CMC projects and prepare CMC regulatory submissions.
- Actively participate in project team meetings and provide leadership in meeting submission goals
- Identify and manage resolution to routine and complex issues including regulatory risk and provide risk/benefit strategies
- Global responsibility for regulatory submissions
- Responsible for support of global registrations
- Sound basis of Scientific (Training/Communications) knowledge in multiple areas
- Expert knowledge of regulations, and experience with interpretation and application
- Excellent written and verbal communication, presentation, and facilitation skills
- Strong negotiation skills and significant experience in interacting with regulatory authorities
- Risk identification and problem solving skills
- BS required in related scientific discipline with a minimum of 5 years of regulatory experience
- MS degree and 6 years of regulatory experience.
- PhD and 2 years of regulatory experience.
Source One Technical SolutionsWhy Work Here?
We are a well-established (20 years in business) consulting services company headquartered in Branchburg, NJ.
A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.
AddressFort Worth, TX
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