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JOB TITLE: REGULATORY AFFAIRS MANAGEMENT I
CAREER LEVEL: D
Lead the way for a new breed of solutions-oriented Regulators
Promote a new regulatory strategy that encourages prompt decisions and responsible risk-taking. We take an active, strategic approach earlier in the product lifecycle as curious, business-minded individuals to participate in directing medical development.
Be part of the team where you are empowered to follow the science
Participate in the solution by helping to make our medication development plans a reality. To achieve the best outcomes for AstraZeneca, patients, and healthcare professionals, work to translate our science into medicines at all phases of development.
ABOUT THE ROLE
The Regulatory Affairs Manager I is a regulatory expert with project management skills who is in charge of overseeing the planning, coordinating, and execution of assigned deliverables from beginning to end, including, if necessary, delivery as an individual contributor. The Global Regulatory Execution Team (GRETRegulatory )’s Affairs Manager I may be responsible for a variety of duties, including Global Labelling Management, Dossier Management, and Regulatory Affairs Management. When given these various accountabilities by their line manager or the Lead Regulatory Project Manager (RPM) for their designated GRET, the Regulatory Affairs Manager I is expected to be able to work flexibly (s).
The Manager of Regulatory Affairs I am fully capable of using established standards to manage regulatory matters for straightforward to somewhat complicated items and areas while working with little oversight. competent to serve as a cross-functional activity leader. participates in process, tool, and system improvement.
Regulatory Affairs Management
Contributes to the regulatory submission strategy by identifying submission risks and opportunities, directing straightforward through complicated regulatory applications, and overseeing the approval process. helps cross-functional teams working flexibly within and across regions to meet business objectives by offering regulatory expertise and direction on procedural and documentation requirements. This is done through the Global Regulatory Strategy Team (GRST).
Global Labelling Management
Possesses knowledge of regulatory labelling and oversees the upkeep of all global labelling documentation for allotted products. carries out the coordination, development, and implementation of the amended printed labelling for allotted products, including USPIs and other regional labelling, under the regulatory authority.
Dossier Management
Designs and oversees the core Clinical and Non-Clinical publishing deliverables, along with the lifecycle and licence data that goes with them. collaborates with publishing teams to ensure timely and effective completion of submission output.
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, executes and maintains submission delivery plans, submission content plans, and proactively provides status updates to designated stakeholders.
- Coordinates the input, maintenance and revision in the project planning 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 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 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.
- Contributes 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. 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 respond to issues arising.
- Interprets 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
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, 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
