Regulatory Affairs Specialist Consultant

at  ClinChoice

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 Specialist Consultant 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.

EDUCATION AND EXPERIENCE:

Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years
years regulatory experience within med tech/ pharmaceutical company, CRO or similar organization.
Higher degree/PhD will be an advantage.
Number of years of experience: 2
Field of expertise: RA in medtech/ pharmaceutical company, CRO or similar organization.

DESCRIPTION

Basic knowledge required
Microsoft Office tools, interest in IT applications, experience with RIM is an advantage

FUNCTIONAL REQUIREMENTS & COMPETENCIES

Sound basis of regulatory knowledge
Scientific knowledge
Strong oral and written communication skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

MAIN JOB TASKS AND RESPONSIBILITIES:

Responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for products and provides communication of general regulatory requirements in support of licensing of Clients products.
Contact point for local regulatory authorities regarding products in Slovakia
Monitor applicable regulatory requirements; assure compliance with client and external standards
Establish appropriate communication within RA and with other functions
Perform regulatory gap analysis and propose solutions
Develop and document sound regulatory decisions and justifications
Ensure regulatory strategies are aligned with project teams and country business objectives
Review promotional material and SOPs for compliance with local and global regulations
Partners with country business in country goals achievement
Represent RA function on assigned cross-functional project teams

SPECIFIC ROLE REQUIREMENTS AND SKILLS:

Languages Skills Spoken Written Read English
Mother tongue :Slovak
Computer Skills