Job title: Regulatory Affairs Manager II
Company: AstraZeneca
Job description: JOB TITLE: REGULATORY AFFAIRS MANAGER II 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 Accountabilities/Responsibilities: • 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, 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 submissions throughout the product’s life cycle from either a global and/or regional perspective. • Develop, implement and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated customers. • Coordinate the input, maintenance and revision in the Planit 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 GRO, MCs, CROs and/or alliance partners where relevant. • Provide coaching, mentoring and knowledge sharing within the RAM skill group. • Contribute to process improvement. Minimum Requirements –Education and Experience • Relevant University Degree in Science or related team • Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience • General knowledge of drug development • Strong project management skills • Leadership skills, including experience leading multi-disciplinary project teams Preferred Experience • Minimum 8 to 10 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 • Regulatory experience • Managed regulatory deliverables at the project level • Thorough knowledge of the drug development process • Knowledge of AZ Business and processes Skills and Capabilities • Excellent 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 collaborator 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 https://www.linkedin.com/company/1603/ 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 03-Nov-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: Sat, 05 Nov 2022 05:27:00 GMT
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