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 Associate, Regulatory Affairs Consultant
Senior Regulatory Affairs Associate-Biologics
• Around 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
• Contribute to 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.
• Preparation and review of Marketing Authorization Applications & Variations forvarious types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
• Preparation of documentation for different types of Variation procedures like Super grouping,
• Grouping and Work-sharing to the Marketing Authorizations.
• Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
• Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions
• Liaise closely with cross-functional members with aligned product responsibilities.
• 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 perform post Approval CMC related updates.
• Working experience in Regulatory Information Management Systems like Veeva Vault.
• Strong communications skills and ability to guide and mentor team members.
Regulatory Affairs Consultant
• Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of 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, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
• Responsible for managing (Authoring and Review) of biologics/biosimilar/vaccine investigational product submission such as IND & IMPD for USFDA, EMA
• Authoring, review, and submission of BLA/MAA dossiers for US/EU/ROW /India markets.
• Preparation of regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, CTA, BMF, BLA, NDA, and MAA applications.
• Life cycle management (LCM) for approved products. (annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN)
• Evaluation of change controls and deviations and defining regulatory strategy
• Preparation and submission of scientific advice, briefing book, Type 2 meeting packages for USFDA and EMA
• Co-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible.
• Develop up-to-date knowledge about regulatory guidelines and applies regulatory requirements and their impact on submissions.
• Working experience in Regulatory Information Management Systems like Veeva Vault.
• Strong communications skills and ability to guide and mentor team members.
• Ability to work independently.
Additional Information
Location : Bengaluru, Chandigarh, Mohali, Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory
End Date : 30th March 2024
Senior Regulatory Affairs Associate
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