Job title: Regulatory Affairs Manager 1
Company: AstraZeneca
Job description: JOB TITLE: REGULATORY AFFAIRS MANAGER I
CAREER LEVEL: D
Lead the way for a new breed of solutions-oriented Regulators
Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development
Be part of the team where you are empowered to follow the science
Be part of the solution, turning our drug development strategies into reality.
Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..
About astrazeneca
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development
About the team
We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.
About the role
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 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.
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, implement and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated collaborators.
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 applying 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 field
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
WHY JOIN US ?
We believe there’s always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.
Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to make valuable contributions throughout
SO, WHAT’S NEXT?
Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
Date Posted 25-Oct-2022
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Expected salary:
Location: Bangalore, Karnataka
Job date: Wed, 26 Oct 2022 23:05:45 GMT
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