Parexel International Corporation Hiring SENIOR REGULATORY AFFAIRS ASSOCIATE B.Pharm, M.Pharm or any life sciences Apply Now
RESPONSIBILITIES
• 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.
B.Pharm, M.Pharm or any life sciences related discipline
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