O pozici
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Co budeš dělat
- Ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously.
- Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance.
- Execute activities to obtain or update establishment registration licenses.
- Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates.
- Request and follow-up of documentation to prepare registration dossiers.
- Supports regional team on product submissions schedules, prioritization, and pipeline management.
- Support internal and external audits with documentation requests.
- Interacts with other stakeholders, government agencies in a professional, decisive, & articulate manner.
- Act as a point of contact for stakeholders to support business plans and regulatory needs.
- Review labels compliance in internal system.
- Support projects as representative of the subject/country.
- Elaborate procedures of the area.
- Organize team meetings and elaborate agenda and minutes.
- Manage quality issues.
- Manage compulsory certification (INMETRO) and GMP activities.
Koho hledáme
- Must have 1-2 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for Brazilian Health Authorities and a successful track record.
- Desirable experience in Medical Devices or Pharma background.
- A Bachelor’s Degree in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience. Advanced reading and writing Skills in English are required; intermediate to advanced speaking is desirable. Fluent in Portuguese.
