Clinical Regulatory Affairs Career Research and Resources

Actavis

Science & Biotech - Clinical Regulatory Affairs - Sunrise, FL

Fulfilled pivotal role in design and implementation of regulatory strategy. Lead/wrote/reviewed ANDA submissions, amendments and supplements, and manage the daily regulatory activities. Cross-functional team member prioritizing and planning timelines for ongoing and potential projects. Project management role ensuring future issues and risks are addressed. • Increased role in the operational management of Actavis South...

Avg. Salary: $226,000   ·    Company Rank: Not Available

Actavis

Science & Biotech - Clinical Regulatory Affairs - Sunrise, FL

Developed RA department. Coordinated and compiled ANDAs. Responded to all FDA deficiencies and inquiries on submitted products. Compiled quarterly and annual reports to FDA for approved products. Fulfilled the Manager and Associate Director, Project Management role. Point of contact for all FDA inquiries.

Avg. Salary: $226,000   ·    Company Rank: Not Available

Actavis

Science & Biotech - Clinical Regulatory Affairs - Sunrise, FL

Point of contact for coordination of all CRO activities to perform pilot and pivotal studies. Planned and coordinated all activities from API to finished product distributor for current commercial product. Continued fulfilling project manager role.

Avg. Salary: $226,000   ·    Company Rank: Not Available

Actavis

Science & Biotech - Clinical Regulatory Affairs - Sunrise, FL

Full life-cycle responsibility for assigned projects from concept to market launch including facilitating and collaborating to create and execute the project plan, acting as liaison between project stakeholders, and monitoring and controlling resources to meet stated goals. Interacted with multi-functional groups such as formulation development, analytical, regulatory, quality, and marketing.

Avg. Salary: $226,000   ·    Company Rank: Not Available

Elan

Science & Biotech - Clinical Regulatory Affairs - Miramar, FL

Collaborated with global program management office and local project managers to ensure standardization of forms, performance reports, and change notice system. Maintained Intranet site on all local projects as key information-sharing tool.

Avg. Salary: $226,000   ·    Company Rank: Not Available

Elan

Science & Biotech - Clinical Regulatory Affairs - Miramar, FL

Provided guidance, leadership, management, and planning to a multidisciplinary project team including timings, milestones, critical path, resource, and risk analysis. Provided feedback and updates on project progress to upper management for strategic planning and budgeting

Avg. Salary: $226,000   ·    Company Rank: Not Available

Elan

Science & Biotech - Clinical Regulatory Affairs - Miramar, FL

Avg. Salary: $226,000   ·    Company Rank: Not Available

Elan

Science & Biotech - Clinical Regulatory Affairs - Miramar, FL

Avg. Salary: $226,000   ·    Company Rank: Not Available

Elan

Science & Biotech - Clinical Regulatory Affairs - Miramar, FL

Avg. Salary: $226,000   ·    Company Rank: Not Available

Elan

Science & Biotech - Clinical Regulatory Affairs - Miramar, FL

Avg. Salary: $226,000   ·    Company Rank: Not Available