PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Regulatory Affairs Consultant
• Around 7-10 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals) in various markets.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
• Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
• Experience in handling CMC related health authority queries
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries ..
• Liaise closely with cross-functional members with aligned product responsibilities.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• To prepare, review and submit safety variations to Health Authorities and also perform post Approval CMC related updates (where applicable).
• Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable
• Strong communications skills and ability to guide and mentor team members.
• Ability to work independently.
Experience : 2-5 years
Location : India - Any Region - Home Based
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th February, 2022
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