AMPLEXOR Adriatic – a member of AMPLEXOR International - is an innovative and agile company serving top pharmaceutical companies around the globe.
We develop and implement best-in-class IT solutions managing regulated processes and content in the Life Sciences industry.
Our business is continuously expanding, therefore, we are looking for a highly motivated individual with passion for Life Sciences to join our Product Team as a Life Sciences Consultant, eSubmission Specialist.
As a Life Sciences Consultant, eSubmission Specialist you will:
- Acts as a Subject Matter Expert for electronic submissions; eCTD/NeeS publishing, submission requirements & formats, procedural guidance
- Acts as a Subject Matter Expert for general dossier/submission production topics across the drugs product lifecycle
- Responsible to monitor the regulatory environment in regard to electronic submissions, to identify and interpret new and modified international standards, regulations, best practices and technical specifications (i.e. ICH, eCTD) and to translate resulting requirements into product requirements and solutions
- Delivers onsite or remote submission management & publishing trainings to clients and internal staff
- Participates in discussions/workshops with clients regarding submission management & publishing questions, consult clients towards best implementation decisions
- Consults internal teams in regard to customer support / questions for submission management & publishing topics
- Writes specifications for new product features, reviews and tests solutions and facilitate the knowledge transfer with preparation of end user documentation for submission management & publishing topics
Your office will be in Zagreb, Croatia or remote
- Degree in a Life Science or related discipline (minimum BA/BS degree)
- Higher degree preferable (MSc, MBA)
- Fluent command of spoken and written English
- Additional languages are a plus
- Ability to work co-operatively and effectively in a team
- Good training and communication competence
- Good analytical and problem solving skills
- Attention to detail in composing, keying and proofing business materials
- Ability to travel as required – approx. 25%
- 5 or more years’ experience in regulatory affairs and/or regulatory operations, or equivalent
- 3 or more years of experience in publishing including eCTD and NeeS is essential
- Solid knowledge of submissions management and publishing systems and processes
- Comprehensive knowledge electronic submission standards, eCTD/NeeS, submission requirements and formats
- Experience in preparation and submission of a full submission/or large variation/supplement through to authorization
- Experience in preparation of regulatory documentation for use worldwide including CTA/IND/Marketing applications/responses to questions/routine regulatory maintenance activities for authorizations is a plus
- Experience with regulatory agency interactions and preparation of documentation to support interactions is a plus
Knowledge of international regulatory affairs is a plus
AMPLEXOR offers continuous trainings and development, competitive remunerations in accordance with employee performance, a pleasant working environment and teamwork spirit.
If you are diligent, willing to learn and are not afraid to take the challenge and to stretch your own thinking, AMPLEXOR will provide a stimulative environment enabling you to shape your career path and realize your full potential!