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 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.
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, executes, and maintains submission delivery plans, and submission content plans, and proactively provides status updates to designated stakeholders.
Coordinates the input, maintenance, and revision of the project planning tools for assigned projects, and highlights unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
Identifies regulatory risks and proposes 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 utilizing the support and input of Global Regulatory Operations, Marketing Companies, CROs, and/or alliance partners where relevant.
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,.
Provides coaching, mentoring, and knowledge sharing within the regulatory organization.
Contributes to process improvement.
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 proposes options to mitigate risks. Respond 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 responds to issues arising.
Interprets technical innovation and Health Authority initiatives; provides 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
Minimum Requirements –Education and Experience
Relevant University Degree in Science or related discipline
Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labeling and publishing, and 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
Having experience in Regulatory information management system
Managed regulatory deliverables at the project level
Experience in working with people from locations outside of India, especially Europe and/or the USA
Skills and Capabilities
Excellent English is written and verbal communication skills
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)
Other R & D skill groups, eg, Global Regulatory Operations, Global Labelling Group, Operations Regulatory, Patient Safety