Represent CLR and serve as an ambassador for other senior leaders across the organization in various capacities, which may include advisor home office visits and speaking with regulators, vendors, recruits, etc.
September 02, 2022
Develop a positive business/functional unit culture by promoting values that focus on patients, science, and bringing forward effective regulatory strategies.
September 22, 2022
Requires a minimum of 15 years of progressively responsible experience in a pharmaceutical, biotechnology, contract research organization, or related environment.
January 31, 2023
Manage relationships with key stakeholders in Technical Operations and Quality and across Regulatory Affairs to provide CMC regulatory support in achieving strategic objectives.
March 23, 2023
Prepares detailed file summary responses for submission to multiple regulatory, legislative, and accreditation agencies, including local, state, and federal government in response to regulatory complaint on the part of members.
March 24, 2023
Responds to regulatory complaint inquiries, which may be written or verbal, prompted by either/or agencies, executive inquiries (for executives), independent medical inquiries, and those prompted by administrative legal hearings.
March 26, 2023
Lead regulatory coverage and oversight in all CMC submissions (including clinical trial, marketing and post-marketing applications, routine reports/renewals) and ensure that submissions comply with applicable global regulatory requirements as well as company policies and procedures, with the goal of obtaining the earliest possible product approvals.
April 06, 2023
Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation.
April 07, 2023
Collaborate with other senior leaders on the team and in the organization to innovate and find ways to optimize core processes through advanced techniques such as artificial intelligence and machine learning.
April 11, 2023
Provides strategic regulatory direction and mentorship on programs including the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management and Health Authority interactions.
April 18, 2023