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Regulatory Affairs Manager I/II
4 days ago
Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
Submission delivery strategy of all dossiers including established brands and all application types per market and /or region including Divestments, Marketing authorization transfer (MAT) and withdrawals.
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.
Liaises closely with cross-functional members with aligned product responsibilities.
Develops, completes and maintains submission delivery plans, submission content plans using digital tools like Veeva Vault (ERV) and compliance, and proactively provides status updates to designated team members.
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 using 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.
Chips in to process improvement.
Regulatory Transition Lead:Attend core transition team meetings to provide regulatory status updates and communicate relevant cross functional updates back to GRET.
Ensure Regulatory Project Management dashboards and trackers are maintained to an agreed schedule.
Maintain overall RA workstream risk/issue/action log and follow up with cross functional teams for appropriate resolution.
Align regulatory transition strategy with other functions
Work closely with Marketing Companies to manage any issues.
Co-ordinate and engage in collaborator communication.
Engage Alliance Integration Management (AIM) lead in appropriate issue partner concern.
Maintain all project documentation in Project SPOL or BOX site, including documentation to substantiate mutual acceptance of achievement status with external workstream lead counterpart.
Be proactive in ensuring the successful completion of the RA activities required for the asset transfer to the project achievement plan.
Collect and collate comments and decisions on regulatory transition plans on regular basis.
Lead the preparation of DoAs for markets where activities transfer before licences
Set up and lead Green Light meetings with Marketing Companies and cross functional counterparts to ensure that full agreement is obtained before a licence transfer is submitted
Ensure all transitions are supervised and updated using ERV, and documents uploaded to ERV as required.
Draft and ensure review and completion of regulatory documentation required for submissions.
Minimum Requirements –Education and ExperienceRelevant University Degree or equivalent experience in Science or related subject area
Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets.
Good understanding of the drug development process.
Thorough knowledge of the regulatory product maintenance process.
Thorough scientific knowledge sufficient to understand all aspects of regulatory/ and partnership issues.
Strong project management skills.
Leadership skills, including experience leading multi-disciplinary project teams.
Flexibility in timing commitment to deals.
Excellent written and verbal communication skills.
Consistent track record to work across cultures.
Preferred ExperienceRegulatory Affairs experience across a broad range of markets.
Managed regulatory deliverables at the project level.
Knowledge of new and developing regulatory and pharmacovigilance expectations
Able to influence whilst maintaining independent and objective view.
Collaboration skills and relationship builder.
Strong negotiation, conflict management and interpersonal skills.
MS/PhD in scientific team.
Knowledge of AZ Business and processes.
Knowledge of existing AstraZeneca external alliances and collaborative projects.
Experience of working with third party suppliers.
Knowledge of Veeva vault (ERV) for submission, compilation, publishing and approval processes, standards, systems and CTIS tools.
Experience of working with people from locations outside of India, including Europe and/or USA, plus International markets.
Skills and CapabilitiesExcellent English written and verbal communication skills.
Cultural awareness
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions.
Proficiency with common project management (, MS Project) and document management tools.
Basic understanding of emerging technologies like Artificial Intelligence
Demonstrate ability to use digital tools and solutions relevant to own work tasks to support productivity, collaboration, and learning.
Work proactively to understand future needs and opportunities for digital transformation that improve the effectiveness and speed of core business processes and decision making.
Ability to work independently and as part of a team.
Influencing and collaborator leadership 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 LinkedInWe 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 Posted25-Jun-2024
Closing Date08-Jul-2024
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