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Post : Regulatory Affairs Manager II
Job Description
The Regulatory Affairs Manager II is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor. The Regulatory Affairs Manager II may take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET): Regulatory Affairs Management, Global Labelling Management and Dossier Management. The Regulatory Affairs Manager II is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their line manager or by the Lead Regulatory Project Manager (RPM) for their allocated GRET(s).
Regulatory Affairs Management
Chips in to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. Provides regulatory expertise and guidance on procedural and documentation requirements to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Global Labelling Management
Provides regulatory labeling expertise and leads the maintenance of global labeling documents for allocated products. Is responsible for the regulatory activities involved in the coordination, development and implementation of revised printed labeling for allocated products, including USPIs and other regional labeling.
Dossier Management
Plans and handles Regulatory and basic Clinical and Non-Clinical publishing results, as well as associated lifecycle and license information. Collaborates with publishing teams to assure efficient delivery of end to end submission output to project timelines.
Accountabilities/Responsibilities
Regulatory Affairs Management
• Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
• Submission delivery strategy of all dossiers and all application types per market and /or region.
• Review of documents (e.g. response documents, study protocols, regulatory maintenance documents, PSRs, etc.).
• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Uses and shares standard methodologies, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Leads and / or contributes 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.
• Liaises closely with cross-functional members with aligned product responsibilities.
• Develops, completes and maintains submission delivery plans, submission content plans, and proactively provide status updates to designated collaborators.
• Coordinates the input, maintenance and revision in the project plannning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identifies regulatory risks and propose mitigations to Lead RPM and cross functional teams.
• Supports operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management applying the support and input of Global Regulatory Operations, Marketing Companies, CROs and/or alliance partners where relevant.
• Provides coaching, mentoring and knowledge sharing within the regulatory organisation.
• Chips in to process improvement.
Global Labelling Management
• This will include:
• the maintenance of core labeling documents including the Core Data Sheet, and Core Patient Information Leaflet, including labelling history documents.
• the maintenance and corporate approval of EU SmPC and US PI and packaging component labeling while ensuring consistency with applicable core labeling documents and internal standards and SOPs.
• Ensuring that updates to the core texts are completed, communicated to and implemented by MCs in a timely manner and deviations are agreed and documented appropriately.
• Ensures that appropriate, up-to-date records are maintained for compliance, including maintaining repositories of current regional labeling and ensuring proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents,.
Dossier Management
• Contributes proactively to resourcing submission deliverables through liaison with internal Global Regulatory Operations or outsourcing partners.
• Leads the dossier management deliverables for divestment of products
• Identifies potential regulatory risks to the operational plans, including publishing and regulatory information management, and propose options to mitigate risks. Responds to market needs and compliance risks with Registration Licenses
• Plans and manages publishing deliverables, as well as associated lifecycle and license information
• Proactively oversees the execution of publishing delivery and respond to issues arising.
• Interpret technical innovation and Health Authority initiatives; providing communication of regulatory information about products (approvals, license events, market priorities, and legacy issues with products) for GRET.
• Ensures that appropriate, up-to-date records are maintained for compliance, including:
• Leads total publishing and Regulatory Information Management deliverables at the Regulatory project team for allocated products
• Develops and maintains strong partnerships with internal and external customers and partners.
Candidate Profile
• Relevant University Degree in Science or related discipline
• Minimum 8 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets General knowledge of drug development
• Thorough knowledge of the regulatory product maintenance process
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams.
• Regulatory affairs experience across a broad range of markets
• Managed regulatory deliverables at the project level
• Experience of working with people from locations outside of India, especially Europe and/or USA
• Excellent English written and verbal communication skills
• Cultural awareness
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (e.g., MS Project) and document management tools
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Ability to analyze problems and recommend actions
• Continuous Improvement and knowledge sharing focused.
Additional Information
Experience : Minimum 8 years
Qualification : University Degree in Science
Location : Bangalore
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 30th November, 2023
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