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.
Main Job Tasks and Responsibilities:
SUMMARY
- Supporting the RA team for submissions and maintenance of new and existing marketing authorizations for Medical Devices and Pharma in the GCC countries (Bahrain, Kuwait, Oman, Qatar, and United Arab Emirates) .
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Regulatory Affairs:
- Develop and execute regulatory plans including new products and maintenance of licenses/authorizations for existing marketing authorizations.
- Handling the regulatory responsibilities in markets under scope (GCC countries).
- Represent the RA function on assigned cross-functional project teams.
- Monitor applicable regulatory requirements; ensure compliance with Baxter and external standards.
- Proactively remain up to date with regards to information relating to the changing regulatory landscape and contributes to recommendations for internal adaptations to help others operate optimally.
- Establish appropriate communication within RA and other functions primarily at project level.
- Perform gap analysis for regulatory projects and propose solutions.
- Develop and document sound regulatory decisions and justifications.
- Ensure business objectives and deliverables are aligned with regulatory strategy.
- Proactively addresses potential regulatory risks by promptly gathering necessary information and using defined processes to resolve or escalate issues.
- Timely submissions of safety updates & Labeling updates to local Health Authorities (according to local regulations) once approved in the country of origin.
- Update any related data and sheets and provide RA assessments as per local HA regulations in a timely manner.
- Communicate local HA circulars & guidelines to all concerned departments.
- Maintain global SharePoint and systems up to date as per global instructions.
- Compliance with Baxter Regulatory processes.
- Notification of MD registration to the distributor.
- Baxter RA Database maintenance and Archiving (RIM – CCDS – Trackwise – Labeling system).
- Promotional Materials review and approval
- Serve as primary contact for the Marketing / Business team to provide the relevant product information to be used on promotional materials.
- Review and approve promotional material and related activities to ensure accuracy and compliance with established regulatory standards through the dedicated system (e.g. Promo Mats).
- Obtain HA authority approval for promotional materials and events (where applicable)
- Labelling activities
- RA labeling responsibility is limited to country/ME specific code.
- Responsible to follow Baxter labeling process & guideline as per the Most updated SOP.
- Middle East shared codes: provide assessments and review final artworks proceeding with final sign off in a timely manner.
- Country specific code: maintain country specific codes up to date as per latest global safety updates and in compliance with local HA regulations.
- Create artworks for newly created codes.
- Tender support :
- Support Business in Tender requests by providing regulatory advise & necessarily regulatory documentation.
JOB REQUIREMENTS
- Ability to manage complex projects and timelines in a matrix team environment.
- Strong oral and written communication and presentation skills.
- Demonstrated interpersonal skills including strong negotiation skills.
- Ability to independently identify compliance risks and escalate when necessary.
Education/Experience
- Bachelor’s degree or country equivalent in related scientific discipline (Pharmacy or Biomedical Engineering or other related degree).
- Minimum 1-5 years’ experience in Regulatory Affairs within the Medical device industry.
- Hands-on experience in preparing regulatory submissions during development and for marketing authorizations.
- Excellent written, verbal communication and presentation skills.
- Strong interpersonal skills with the ability to influence others in a positive and effective manner.
- Excellent organizational skills and ability to support multiple projects.
- Ability to communicate clearly, succinctly and effectively.
- Ability to work as a member of a team in a timeline-driven environment with limited supervision (mostly in a multi-cultural environment) .
- Demonstrated ability to contribute to a continuous learning and process improvement environment.
Languages Skills
Spoken
Written
Read
English
Must
Must
Must
Arabic
Must
Must
Must
French
NA
NA
NA
Computer Skills
Description
Basic knowledge required
Word, Excel, Outlook, PowerPoint
Particular knowledge required
GCC regulations for new registration and product lifecycle management
Top Skills
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
