Regulatory Affairs Associate I
Navi Mumbai, India, 400706
Who we are
The opportunity
Providing regulatory support for European and International Markets RA.
How you’ll spend your day
- Completion of designated projects and tasks supporting European Market RA and International Market RA, according to internal Work Instructions, with guidance and direction by the manager and more senior colleagues.
- Maintaining related documentation and regulatory IT systems, in line with internal procedures.
- Timely task completion in line with Work Instructions, with accurate tracker updates and adherence to compliance standards.
- Communication with Teva units across Europe and International Markets, with 3rd Parties and with related Health Authorities.
- Fulfilling other allocated department duties and ad-hoc tasks as directed by senior regulatory affairs staff.
- Completion of trainings assigned in Teva internal learning management system within defined timeframes.
- Attending team meetings and providing regular updates on the assigned activities and tasks to the manager and/or to senior regulatory affairs staff.
- Maintaining and developing awareness of the current/pending regulatory legislation and guidelines.
Your experience and qualifications
Qualification:
- Masters in Pharmacy or Masters in Science/Life Sciences
- College or University degree or equivalent work experience that provide knowledge of and exposure to fundamental theories, principles and concepts.
Experience:
- 2-3 years of experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered.
- Experience of regulatory documentation within Europe and/or International Markets.
Knowledge
- Work experience involving core regulatory concepts and procedures.
- Ability to use existing internal procedures to solve routine or standard problems.
- Proficient in regulatory IT systems to support compliance and documentation processes.
- Working knowledge of Office-365 applications and Veeva Vault systems.
- Strong focus on Compliance and regulatory standards.
- Basic knowledge of project management principles and tools.
- Strong organizational skills to meet self, team and company goals.
- Ability to identify a problem or need for decision that exceeds the competence of the individual.
- French and/or German language proficiency will be an added advantage.
Teva’s Equal Employment Opportunity Commitment