Regulatory Affairs Specialist 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 a Regulatory Affairs Specialist Consultant (Remote) 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.

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

1. REGULATORY AFFAIRS

Maintain appropriate positive contacts with regulatory officials to enable the clear understanding of requirements and the defence of Clients positions when appropriate.

Perform and/or review the translation of labelling

Review promotional materials for use when applicable

Prepares regulatory applications of medicines and medical devices to achieve product licensing and registration and maintains current registrations. This involves the following tasks:

Compile and submit in a timely manner regulatory documents according to regulatory requirements

Prepare review and approve labelling and SOP’s

Provide regulatory advice to project teams.

Respond to regulatory authorities’ questions within strict deadlines.

Maintain regulatory files in a format consistent with requirements

Maintain and update existing regulatory authorizations.

Represent Regulatory Affairs in project teams

Review promotional material for compliance with local regulations

PSURs:

Schedule annually local PSUR if needed.

Submit PSURs to local authority if appropriate.

2. REGULATORY COMPLIANCE

Ensure that relevant policies and procedures established in the country are enforced and that these

procedures comply with the requirements of local law and regulations specifically related to:

release for country distribution.

labelling and advertising of products including national language requirements.

B. Keep track of current regulatory trends in the country.

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.

Specific Role Requirements and Skills:

Languages Skills Spoken Written Read English

Mother tongue :Slovak

Computer Skills

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.

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 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific .

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 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 Submission PSURS LABELLING

#LI-PB1 #LI-REMOTE