Teva Pharmaceuticals, a global leader in generic medicines, is dedicated to making healthcare accessible and affordable for millions of people worldwide. With operations in nearly 60 countries, Teva’s diverse workforce drives the mission to deliver high-quality pharmaceutical products. Their portfolio includes essential medications that benefit over 200 million people every day, showcasing their commitment to improving global health outcomes.
As a Regulatory Affairs (RA) Associate I, you will be responsible for managing the lifecycle of Medis dossiers for Teva’s third-party client business. You will act as a Project Manager (PM) and collaborate with various stakeholders to ensure smooth regulatory operations. Below are the key responsibilities associated with this role:
- Lifecycle Management: Handle the lifecycle management of specific products for European and international markets.
- Compliance: Ensure regulatory modules are updated regularly as per the applicable procedures.
- Variation Submissions: Prepare, submit, and follow up on variations with the appropriate regulatory authorities or Teva’s third-party business (Medis).
- Response Management: Compile responses to deficiency questions from regulatory authorities or clients.
- Stakeholder Communication: Ensure timely communication of variation outcomes to stakeholders and keep databases updated.
- Status Updates: Provide regular status updates to management.
- Project Goals: Set and follow up on goals in collaboration with your supervisor.
- Coordination: Work on specialized projects as required by the RA department.
- Communication: Maintain professional relationships with internal and external stakeholders.
Qualifications for Regulatory Affairs Associate I
To succeed in this role, candidates must meet the following educational and experience requirements:
- Educational Qualifications:
- M.Pharm/M.Sc: 2 to 3 years of experience in Regulatory Affairs.
- B.Pharm/B.Sc: 3 to 5 years of experience in Regulatory Affairs.
- Relevant Experience:
- A minimum of 1 year of experience in EU Regulatory Affairs is required.
Essential Skills for Success
Teva Pharmaceuticals seeks candidates with the following skill set:
- Organizational Skills: Strong ability to manage multiple tasks and projects effectively.
- Communication Skills: Excellent written and verbal communication, with fluency in English.
- Strategic Thinking: Ability to adapt to changes and think proactively.
- Teamwork: Collaborative and effective as part of a team.
- Independence: Able to work independently with minimal supervision.
- Technical Skills: Good computer skills and familiarity with databases and regulatory software.
