Analyst Regulatory Affairs Consultant

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 Analyst Regulatory Affairs Consultant with Hybrid option for 12 months CONTRACT and renewable, to join one of our major consumer products clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. 

Position Summary

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 JJ 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.

Competencies

• Knowledge of Local & International Regulation and Processes
• Analytical capability and investigative skills
• Self-motivated and committed to a team approach
• Communicates clearly and effectively.

• Prioritizes work to meet deadlines
• Planning and Organizing skills
• Understands the importance of the adherence to compliance
• Project Management skills and ability to manage complex data with excel spreadsheets are desirable

 

GLP Behaviors

• Collaboration and teaming
• Results & Performance Driven
• Sense of Urgency

• Integrity & Credo-based Actions
• Intellectual curiosity
• Self Awareness & Adaptability

 

Experience/ Qualification  Requirements

• 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.

Education Requirements

·       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.

 

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

 

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

 

Key words: Regulatory Affairs, Consultant

#LI-PB1 #LI-Hybrid #Contract