Senior Regulatory Affairs Manager

Veristat

6d•$125 - $160•Remote

About The Position

Senior Regulatory Affairs Manager The Senior Regulatory Affairs Manager manages assigned regulatory and cross-functional projects; provides strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products and plays a key role in providing consultation to Veristat’s clients, in translating regulatory requirements into practical application to ensure the success of clinical trials and regulatory submissions. S/he will work with project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of submissions, and create strong rapport with clients. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years Flexible, inclusive culture — 70% remote workforce, 66% women-led teams Learn more about our core values here!

Requirements

Bachelor’s degree in a related field required.
6 - 8 years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting (or demonstrated ability to function at this level), with a proven track record of global regulatory submissions
As Senior Manager Regulatory Affairs CMC: familiar with manufacturing, specifications, analytical testing and overall regulatory CMC requirements
Thorough knowledge of International Conference on Harmonisation (ICH) guidelines and regulatory guidelines in the relevant territories as well as drug development, clinical trials, and clinical research
Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with drug development, agency interactions, study designs and regulatory requirements that apply to clinical trials are required
Demonstrated ability to develop and foster positive client relationships.
Demonstrated ability to lead by example and demonstrated skill for technical leadership of staff.
Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.

Nice To Haves

Advanced scientific degree (i.e. PhD or Master’s degree) preferred.

Responsibilities

manages assigned regulatory and cross-functional projects
provides strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products
plays a key role in providing consultation to Veristat’s clients, in translating regulatory requirements into practical application to ensure the success of clinical trials and regulatory submissions
work with project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of submissions, and create strong rapport with clients