ASSOCIATE REGULATORY AFFAIRS STRATEGIST

Associate Regulatory Affairs Strategist   The Associate Regulatory Affairs Strategist plays a 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.
They will support project teams, provide advice on regulatory agency interactions, manage routine agency communications, support the preparation of simple to moderate complexity submissions, and create strong rapport with clients.
Depending upon the prior experience of the Associate Regulatory Affairs Strategist, it may be necessary to perform their responsibilities with the oversight of a more senior strategist, until such time as they can demonstrate the ability to work independently.
What we do   For more than 27 years, Veristat has built a reputation as global experts in clinical development.
760+ Rare Disease Clinical Trials supported 160+ Marketing Applications supported In we supported 8 marketing application that received regulatory approval Learn more about our core values here ! What we offer   The estimated hiring range for this role is EUR plus applicable bonus.
This hiring range is specific to and will vary for other regions based upon local market data.
Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to.
skills and experience, licensure and certifications, education, specific location and dynamic market data.
Benefits vary by location and may include.
Remote working Flexible time off Paid holidays Medical insurance Tuition reimbursement Retirement plans What we look for   Bachelor’s degree in a related field required.
Advanced scientific degree (i.
.
PhD or Master’s degree) preferred.
A minimum of two years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting or a Master’s Degree in regulatory affairs preferred.
Will consider candidates with strong scientific credentials and excellent communication skills without any prior regulatory experience, provided suitable oversight/training is possible in the current environment.
Knowledge of International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research preferred.
Ability to integrate scientific and business objectives to ensure a positive commercial outcome.
Excellent written and oral communication skills including grammatical/technical writing skills.
Ability to quickly learn and apply new information, including study designs and regulatory requirements that apply to Phase I-IV clinical trials.
Ability to develop and foster positive client relationships.
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.
Driving/Travel requirements – 0-20% (National, International)