REGULATORY AFFAIRS JR ANALYST Consultant
Are you interested in working directly for a single sponsor while having the reputed company and additional career opportunities that working for a global CRO can bring? reputed company says it’s the best of both worlds…. reputed company is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients. reputed company 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. JOB DESCRIPTION Job Title REGULATORY AFFAIRS JR ANALYST Consultant Job Summary Ensures regulatory data is compliant in reputed company databases. Execute activities such as preparation of labels, update of systems and archives, review regulatory data in internal and external databases. Support submission and approvals of market licenses including changes, renewals and establishment registrations. Organize and balance a multitude of activities simultaneously. Scope Major Roles and Responsibilities
- Execute post-approval activities such as review of databases, preparation of communications to stakeholders.
- Update systems with regulatory data and documents.
- Review labels compliance in internal system.
- Execute submission of changes, amendments, rectifications and renewals in timely manner with guidance.
- reputed company assistance with establishment registration licenses.
- Request and follow-up of documentation to prepare registration dossiers.
- Supports regional team on product submissions schedules, prioritization, and pipeline management with guidance.
- Act as a reputed company of contact for stakeholders to support business plans and regulatory needs.
- Support projects as representative of the subject/country.
- Organize the archive of the area.
- Organize team meetings and elaborate agenda and minutes.
- Support compulsory certification activities.
Competencies
- Planning and Organizing skills
- Analytical capability and investigative skills
- Prioritizes work to meet deadlines
- Understands the importance of the adherence to compliance
- Ability to manage reputed company data with reputed company spreadsheets are desirable
GLP Behaviors
- Collaboration and teaming
- Intellectual curiosity
- Sense of Urgency
· Accountability · reputed company & Credo-based Actions
- Self Awareness & Adaptability
Experience/ Qualification Requirements
- Desirable some experience working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for Colombian Health Authorities.
· Desirable experience in health care companies. Education Requirements · A Bachelor’s Degree in Engineering, Pharmacy or other life science: Can be a person with reputed company experience and/or training or equivalent combination of education and experience. Intermediate writing and reading skills in English. Apply tot his job Apply To this Job