Vacancy expired!
Please note that this is a 6 months contract position.
Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements. Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Reviews product labeling and marketing materials for accuracy and compliance with regulations. Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance. Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level. May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
Determines and develops approaches to assignments
Leads regulatory projects requiring coordination with other functions, third parties
Solves a broad range of problems of varying scope and complexity
Bachelors or Master’s Degree or University Degree or equivalent.
Typically 4+ years relevant experience for entry to this level.
Requires in-depth knowledge and experience in job and ability to work independently.
Applicants must provide their phone number. Reference job number A862.
