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Senior Consultant

2 months ago

Charleston, United States Novotech Full time
Job Description

Responsibilities:
  • Activities will focus on work that facilitates the entry of Clients' compounds into clinical trials. The Senior Regulatory Consultant will also assist with activities required to obtain marketing approval in multiple regulatory jurisdictions.
  • Including but not limited to the drafting and review of regulatory documents such as briefing packages for meetings with regulatory agencies and clinical trial application documents. Direct communication with Regulatory Authorities such as attending scientific advice meetings will be required. Facilitation of regulatory meetings a plus.
  • The Senior Regulatory Consultant will develop regulatory strategies and articulate these to potential and existing Clients. The Senior Regulatory Consultant will manage DDC projects directly and help support other project managers by ensuring the timely completion of all project tasks within the allocated time and budget. The Senior Regulatory Consultant will also support the Business Development team and Senior Management in reviewing proposals before being sent to Clients as required.
Qualifications:
  • Graduate or post-graduate qualification in clinical, pharmacy or life sciences related field.
  • Minimum of five years' experience in regulatory affairs required to support development and approval of pharmaceutical products.
  • Strong proficiency in English usage (both verbal and written with grammar, punctuation, language). Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
  • Highly experienced in the use of MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of FDA regulations required; knowledge of APAC and/or EU regulations a plus.
Salary Band - Senior Regulatory Consultant: $120,000 to $160,000 USD - The salary for this position will be determined based on the candidate's experience and qualifications.

Find out more about working at Novotech at: www.novotech-cro.com/careers

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

Responsibilities
  • Activities will focus on work that facilitates the entry of Clients' compounds into clinical trials. The Senior Regulatory Consultant will also assist with activities required to obtain marketing approval in multiple regulatory jurisdictions.
  • Including but not limited to the drafting and review of regulatory documents such as briefing packages for meetings with regulatory agencies and clinical trial application documents including INDs, IMPDs, CTAs). Direct communication with Regulatory Authorities such as attending scientific advice meetings will be required. Facilitation of regulatory meetings a plus.
  • The Senior Regulatory Consultant will develop regulatory strategies and articulate these to potential and existing Clients. The Senior Regulatory Consultant will manage DDC projects directly and help support other project managers by ensuring the timely completion of all project tasks within the allocated time and budget. The Senior Regulatory Consultant will also support the Business Development team and Senior Management in reviewing proposals before being sent to Clients as required.
Qualifications

Qualifications:
  • Graduate or post-graduate qualification in clinical, pharmacy or life sciences related field.
  • Minimum of five years' experience in regulatory affairs required to support development and approval of pharmaceutical products.
  • Strong proficiency in English usage (both verbal and written with grammar, punctuation, language). Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
  • Highly experienced in the use of MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of FDA regulations required; knowledge of APAC and/or EU regulations a plus.