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, Senior Regulatory Affairs Associate, Regulatory Affairs Associate
Key competencies - Biologics :
• Several years of experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, 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.
• Knowledge of regulatory frameworks, trends, and ICH country CMC requirements for small and large molecules
Key competencies- Labelling
• Strong knowledge of country-specific labeling regulations and guidelines across the US, EU, Canada, Australia, and Switzerland, combined with hands-on experience in label development, including CCDS, USPI, and packaging components.
• Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
• Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
• Must have handled CCDS related submission / safety variations / xEVMPD / Label and artwork updates.
• Experience creating comparator labeling and managing artwork approvals for packaging components per design and legislative requirements
Regulatory Affairs Consultant (Biologics/Small Molecules)
• Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets, mainly US and EU.
• 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.
• 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, and author responses to HA requests.
• Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
• Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
• Authoring CMC component for marketed products, of Annual Reports, Variations, Renewals in EU (Type IA/IB/II/IAIN), and US and RoW markets.
• Evaluation of change controls and deviations and identification of required documentation and strategy for EU/US submissions and other markets.
• Co-ordination with internal and external stakeholders for documentation required for various submissions. Identify quality and/or timeliness issues with source documents, as early as possible.
• Develop up-to-date knowledge about regulatory guideline updates and applying regulatory requirements and their impact on submissions.
• Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.
• Strong communications skills and ability to guide and mentor team members.
• Ability to work independently
• Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.
• Authoring content of the drug product label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
• Familiarity with EU Guidelines for QRD / Excipients.
• Artwork management for countries with label in English.
Senior Regulatory Affairs Associate (Biologics/Small Molecules)
• Around 4-6 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) 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, and author responses to HA requests
• 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.
• Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) 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.
• Author CMC components of Annual Reports and renewals (m 1/2/3), GMP submissions e.g., site registrations
• Providing regulatory impact assessment for any change control and identification of required documentation for EU/US submissions and other markets.
• 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 (RIMS) like Veeva Vault.
• Strong communications skills and ability to guide and mentor team members, and ability to work independently.
• Authoring content of the label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
• Familiarity with EU Guidelines for QRD / Excipients
Senior Regulatory Affairs Associate (Labelling)
• Required minimum 4-6 years of experience in development of labeling of drug products (CCDS, USPI, packaging), product package coordination, supply chain regulatory affairs, and quality.
• Good working knowledge of key labeling regulations/guidance, and managing label updates, compliance, and governance.
• Strong knowledge of regulations pertaining to labelling life cycle management in US, EU, Switzerland, Canada and Australia.
• The ability to research and create comparator labeling documents.
• Strong understanding and experience authoring CMC component of Annual Reports.
• The ability to collaborate with technical teams for artwork implementation.
• Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
• Knowledge of usage of Electronic Document Management Systems and / or electronic submission experience.
• Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
• Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
• Monitor, manage and control artwork changes.
• To manage and maintain the Artwork Trackers & Systems.
• To ensure artwork PDFs are maintained and latest versions are readily available.
• Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved
• Experience with consumer advertising and educational materials
• Working experience in Regulatory Information Management Systems (RIMS) like, Veeva, TVT, Docubridge, etc.
Additional Information
Experience : 2 to 10 years
Location : Bengaluru
Walk in Drive
Date & Time : 20th December, 2025, 10am Onwards
Venue : Arliga Ecoworld, Building No. 5B, 3rd floor, Sarjapur Marathali, Outer Rind Road, Devarabeesanahalli Village, Varthur, Hobli, Bangalore East Taluk, Bengaluru - 560103
Regulatory Affairs Consultant (Biologics / Small Molecules) : Apply here
Senior Regulatory Affairs Associate (Biologics / Small Molecules) : Apply here
Senior Regulatory Affairs Associate (Labelling) : Apply here
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