Company Description
Upwork has partnered with an Enterprise client who is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage and propelled forward by science, their iconic brands are recommended by health care professionals and can be trusted by consumers who use their products to improve their daily lives.
They are in partner with Upwork to find a Regulatory Affairs Specialist in Turkey who would be accountable for all regulatory activities associated with their assigned medicines, medical devices, cosmetics and/or food supplement consumer products within their geographical and/or brand area of responsibility. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.
Job Description
The Roles & Responsibilities include;
Regulatory Strategy
- Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
- Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
- Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
- Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements
Regulatory Compliance
- Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
- Identifies & initiates local process improvement opportunities and manage changes as required
Qualifications
- Knowledge of consumer healthcare environment and product development
- Understanding of processes and departments within a healthcare company
- Effective time and organisation management
- Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
- Good interpersonal skills; able to build effective personal networks internally and externally.
- Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
- Strong organizational and time management skills with an ability to work under pressure.
- Able to work effectively in a multi-cultural, highly matrixed organization
- Proficiency in English