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
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
Candidate Profile
• 8+ years’ experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.
• 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
• Ability to work independently.
Additional Information
Location : India, Remote
Industry Type : Pharma / Healthcare / Clinical research
Job ID : R0000020361
Functional Area : Regulatory
End Date : 10th May 2024
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