Work as Regulatory Affairs Associate at Teva Pharmaceutical
Post : Regulatory Affairs Associate I
• Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
• Ensure approvals are secured within the stipulated timelines and maintain registration.
• Documentation and associated electronic databases, in line with in-house procedures.
• Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
• Priorities, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
• Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
• Maintain and develop awareness of current/pending regulatory legislation and guidelines.
• Fulfilling other allocated department duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel.
• To complete the assigned tasks for new MA approvals and post-approval activities in accordance with the Work Instructions to achieve regulatory compliance.
• Ensure task completion within the stipulated timelines for designated projects.
• Provide regulatory support for EU and Growth markets.
Candidate Profile :
• Degree in science / life sciences / pharmacy or equivalent qualification(s).
• 3-4 years experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered.
• Desirable to have experience with preparation and submission of variations within Europe.
Qualification : B.Sc, B.Pharm
Location : Navi Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th August, 2019
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube