Teva Regulatory Affairs Associate 

India, Karnataka, Bengaluru 

57466736

Providing regulatory support for International Markets RA.

• Completion of designated projects and tasks supporting 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 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.

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.

• 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.