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
Job Description
• 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 . Experience with ROW countries would be a plus.
• Expertise in CTD / eCTD compilation and submissions, technical review of the submission documents as well as Post Approval activities: Renewal, Variations and other lifecycle management activities (preferably for Europe, USA and International markets would be an asset). Exhibit excellent CTD writing skills.
• Comprehensive knowledge and experience with developing regulatory CMC strategies and CMC dossier content requirements.
• Product Portfolios: Generics, Consumer Health, Biologicals/Vaccines etc
• 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.
* 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.
* Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
* Support operational and compliance activities for assigned CMC deliverables, including generating work requests and submission content plans, submission tracking and document management utilizing the support and input of Global Regulatory Operations and Marketing Companies.
* Must able to prepare, review and submit Administrative, CMC related, Labelling as well as Safety variations to Health Authorities and also perform post Approval related updates (where applicable)
• Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents
• Well versed with MA Transfers and related activities preferably for EU and international markets.
• Strong knowledge and experience of CMC gap assessment and defining CMC action plans.
• Determine the types of regulatory submissions or internal documentation that are required in situations.
• Gap regulatory assessment (regulatory strategy) based on relevant HA requirements.
• Preparing and Prioritizing the gap resolution dossier concerning the update of the MA dossier as needed
• Supports Site regulatory product managers with regard Regulatory Gap assessments
• Supports Site project teams and external stakeholders as part of project execution
• Must able to handle Health Authority Queries, Change Control management as well as the coordination and follow ups with internal / external stakeholders and local RA affiliates.
• Must able to perform Artwork reviews
• Assist and provide support in the preparation, distribution and follow up of registration documentation required to affiliates/ regulatory authorities
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
• Exhibits good project management skills.
• Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes.
• Ensure that quality standards are met and that the deliverables meet strict deadlines
• Excellent interpersonal and intercultural communication skills, both written and verbal.
• Attention to details and ability to think strategically
• Multi-tasking ability.
Candidate Profile
B.Pharm, M.Pharm or any life sciences related discipline
Additional Information
Qualification : B.Pharm, M.Pharm
Location : Bengaluru, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : 61664BR
End Date : 30th October, 2020
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