Clinical Regulatory Affairs Career Research and Resources
Deloitte & Touche
Senior Manager (one level below Partner/Principal) Audit and Enterprise Risk Management Governance, Regulatory and Risk Strategies (6/11-present) Responsible for developing and marketing strategic and risk mitigation consulting services to Life Science companies for global regulatory affairs and compliance functions. Successfully secured three project bids. Project lead for a healthcare compliance audit for a client resp...
Avg. Salary: $127,500 · Company Rank: Not Available
Baxter Healthcare
Responsible for all Global Regulatory Affairs activities providing strategic and operational leadership to the development and maintenance of a diverse portfolio of products, including parenteral nutritionals, IV solution therapies, medicinal foods, and novel container closure systems. Accountable for all regulatory submissions globally, ensuring that they meet appropriate standards and content requirements for global and/...
Avg. Salary: $127,500 · Company Rank: Not Available
Acceleron Pharma
Oversaw and managed the direction of regulatory affairs and quality assurance operations for a start-up biotechnology company. Developed and implemented the regulatory strategies for the development of biological therapies in the areas of osteoporosis, adjunctive oncology, and muscle atrophy associated with muscular dystrophy, ALS, and cancer cachexia. Conducted multiple face-to-face meetings with the FDA, defending Phase ...
Avg. Salary: $127,500 · Company Rank: Not Available
Merrimack Pharmaceuticals
Responsible for establishing company-wide regulatory activities, policies and procedures, including the development and implementation of pre-clinical, clinical and manufacturing regulatory strategies. Lead liaison for all health authority (FDA, EMEA, etc.) interactions, including face-to-face meetings, teleconferences, and product issue resolution. Successfully filed two Investigational New Drug (IND) applications for a ...
Avg. Salary: $127,500 · Company Rank: Not Available
Acceleron Pharma
Oversaw and managed the direction of regulatory affairs and quality assurance operations for a start-up biotechnology company. Developed and implemented the regulatory strategies for the development of biological therapies in the areas of osteoporosis, adjunctive oncology, and muscle atrophy associated with muscular dystrophy, ALS, and cancer cachexia. Conducted multiple face-to-face meetings with the FDA, defending Phase ...
Avg. Salary: $127,500 · Company Rank: Not Available
Biogen Idec
Regulatory Team Leader for the following development programs: • Regulatory Team Leader responsible for filing a Marketing Authorization Application (MAA) in Europe for a biological product using the Centralized Procedure. Coordinated clinical and CMC regulatory teams to ensure consistent messaging throughout the dossier, maintaining timelines, and managing authors. Responsible for communicating risks and risk mitigatio...
Avg. Salary: $127,500 · Company Rank: Not Available
Biogen Idec
Regulatory Team Leader for the following development programs: • Regulatory Team Leader responsible for filing a Marketing Authorization Application (MAA) in Europe for a biological product using the Centralized Procedure. Coordinated clinical and CMC regulatory teams to ensure consistent messaging throughout the dossier, maintaining timelines, and managing authors. Responsible for communicating risks and risk mitigatio...
Avg. Salary: $127,500 · Company Rank: Not Available
Genetics Institute/Wyeth
Regulatory Project Leader for an investigational immunosuppressive biologic with clinical indications in solid organ and bone marrow transplantation. The product consisted of 2 novel monoclonal antibodies used in combination. Coordinated all pre-IND activities, submitted 2 US IND applications and managed resolution of regulatory issues pertaining to clinical trial design and the combined use of two novel agents untested in...
Avg. Salary: $127,500 · Company Rank: Not Available
Roxane Laboratories
Strategic planning, New product selection, development and implementation of the Clinical Development plan and regulatory strategies for all new filings. Responsible for all regulatory submissions, approval and lifecycle managment. Lead and Directed the regulatory, medical, labeling, drug safety and risk evaluation mitigation strategies groups/teams.
Avg. Salary: $200,000 · Company Rank: Not Available
Self employeed
Assisted pharmaceutical companies in strategic planning for clinical trials, issue identification, problem solving, and regulatory submissions. Managed medication studies, and ensuried clinical trial centers conducted studies in accordance with GCP standards.
Avg. Salary: $200,000 · Company Rank: Not Available
