Senior Specialist Product Regulatory Affairs

Job Description

POSITION TITLE: SENIOR SPECIALIST - PRODUCT REGULATORY AFFAIRSThe Senior Specialist/Associate Manager I/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 if required. The Senior Specialist/Associate Manager I/II may take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET): Regulatory Project Management, Global Labelling Management and Dossier Management. The Senior Specialist/Associate Manager I/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 Project ManagementContributes 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 ManagementProvides 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 ManagementPlans and manages Regulatory and basic Clinical and Non-Clinical publishing deliverables, 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 Project Management

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide 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.
• Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• 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.
• Coordinate the input, maintenance and revision in the OPAL project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of Global Regulatory Operations, Marketing Companies, CROs and/or alliance partners where relevant.
• Provide coaching, mentoring and knowledge sharing within the regulatory organisation.
• Contribute 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.
• Ensure 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

• Contribute proactively to resourcing submission deliverables through liaison with internal Global Regulatory Operations or outsourcing partners.
• Lead the dossier management deliverables for divestment of products
• Identify potential regulatory risks to the operational plans, including publishing and regulatory information management, and propose options to mitigate risks. Respond to market needs and compliance risks with Registration Licenses
• Plan and manage publishing deliverables, as well as associated lifecycle and license information
• Proactively oversee 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.
• Ensure that appropriate, up-to-date records are maintained for compliance, including:
  • Lead total publishing and Regulatory Information Management deliverables at the Regulatory project team for allocated products
• Develop and maintain strong partnerships with internal and external customers and partners

Minimum Requirements Education and Experience

• Relevant University Degree in Science or related discipline
• 6-11 years 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

Preferred Experience

• 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

Skills and Capabilities

• 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

Internal and External Contacts/Customers

• Global Regulatory Leads (GRLs)
• Regulatory Regional Leads (eg, US, EU, International RADs)
• Lead RPM
• Other GRAPSQA skill groups, eg, Global Regulatory Operations, Global Labelling Group, CMC Regulatory Compliance, Patient Safety
• Other internal Science Unit functions within the GMED
• Operations/Manufacturing organisation (CMC post approval)
• Marketing Companies/Local affiliates
• Health Authorities
• External collaboration partners

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