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 : Senior Regulatory Affairs Consultant - CMC Biologics
Job Description
• Extensive experience in managing new registrations, life cycle maintenance, and renewals for biological products including vaccines, recombinant proteins, monoclonal antibodies, and plasma derived therapies across major markets such as the US, EU, Japan, Canada, Switzerland, and Australia.
• Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
• Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
• 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.
• Strong communication and collaboration skills, ability to work independently.
• The role is for a team lead with expectations to guide/mentor team members on technical aspects including regulatory filings to global markets
Candidate Profile : Minimum of a bachelor’s degree in a Scientific or Technical Discipline, Advanced Degree preferred
Additional Information
Experience : 10 to 14 years of relevant experience
Location : Bengaluru, Hyderabad
Job ID : R0000038656
Regulatory Affairs Consultant : Apply here
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