AstraZeneca Chemistry & Pharmacy Job – Regulatory Affairs
AstraZeneca Hiring chemistry and pharmacy candidates. B Pharma and BSc Chemistry candidates. Candidates with bachelor’s dgeree in chemistry and pharma may apply for the job vacancy at Asterzeneca for the post of Regulatory Affairs Manager. Chemistry and pharma job. Check out all the details on the same below:
Job Title: Regulatory Affairs Manager II
Career level: D
Education, Qualifications, Skills and Experience Essential
• A science/pharmacy/nursing degree, with at least 4 years of relevant experience (pharmaceutical, regulatory, and partnership)
• Experience in working cross-functionally
• Thorough scientific knowledge sufficient to understand all aspects of regulatory/ and partnership issues
• Thorough knowledge of the drug development process
• Good attention to detail
• Flexibility in timing commitment to deals
• Excellent written and verbal communication skills
• Proven ability to work across cultures
• Knowledge of AZ Business and processes
• Able to influence whilst maintaining independent and objective view,
• Strong collaboration skills
• Strong negotiation, conflict management and interpersonal skills
• Relationship builder
• Able to work with high degree of autonomy
• Able to work effectively as a member of a cross-functional or global team
• Understanding of change management
process• Maintains high ethical standards, including a commitment to AstraZeneca values and behaviors
• Good time management
• Fluent in English
• Computer literate
Desirable
• MS/PhD in scientific discipline
• Knowledge of new and developing regulatory and pharmacovigilance expectations
• Knowledge of existing AstraZeneca external alliances and collaborative projects
• Knowledge of ORSSE operating model
• Experience of working with third-party suppliers.
• Experience of working in a global organization, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry
Date Posted
Job Description
- As a member of the Oncology Regulatory Science & Strategy Excellence team, the role holder will work with the Senior Director – Regulatory Business Development, supporting in/out Licensing and Partnership deals and execution of Transition Service Agreement (TSA) whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e., Licensing Partners, Outsourcing Partners).
- The –Post Deal Operations Manager II(PDOM) role sits in the Regulatory Business Development group and is of key importance in the delivery of AstraZeneca business development portfolio to ensure license transition in the most efficient and customer focused manner.
- The PDOM will work closely with a broad cross-functional core transition team, comprised of functional representatives appropriate for the deal. As Post Deal Operations Manager for Regulatory Affairs (RA) you will support the RA Workstream in the core transition team. The PDOM will be accountable for regulatory transition activities to achieve relevant project milestones, as well as core business development operations delivery activities including but not limited to: Green Light Process, Preparation of documentation and Regulatory Activities.
- The PDOM will collaborate with the equivalent external deal partner counterpart to agree the ways of working for the joint workstream team, engage in regular status issue and risk discussions to ensure smooth transitions.
- Working with designated stakeholders to ensure various cross-functional activities are managed with appropriate timing to align with regulatory transitions, including but not limited to documentation review as per Mergers and Acquisition timelines, Patient Safety agreements are in place, supply has appropriate stock builds planned and artwork changes are considered.
Responsibilities:
• Attend core transition team meetings to provide RA status updates, issue reports etc. and to communicate relevant cross functional updates back to global regulatory project team.
• 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 stakeholder communication.
• Engage Alliance Integration Management (AIM) lead in appropriate issue escalation.
• Maintain all project documentation in ERA Box, including documentation to substantiate mutual acceptance of milestone 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 milestone plan.
• Ensure that Pharmacovigilance Agreement is reviewed by Global Regulatory Lead for consistency with milestone 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 green light is obtained before a licence transfer is submitted
• Ensure all transitions are tracked and updated using either SMRT/ Register or ERV, and documents uploaded to CARA as required.
• Draft and ensure review and completion of regulatory documentation required for submissions
• Provide Customer support and expertise: provide expert advice, guidance and interpretation of matters pertaining to Transition Service Agreements (TSA) to ensure that the collective team and partners’ transfer timelines are accurate and deliverable. Using deep understanding of regulatory processes and regulations provide process or compliance support to safety and regulatory teams and submissions.
• Drive Collaboration: work across functions to provide advice and support for commercial agreements, ensuring optimal and compliant regulatory advice and input. Work with Marketing Company Regulatory post deal, providing advice and support for both the MCs & our post deal partners. Building relationships with stakeholders and customers to support regulatory activities and responsibilities including successful partnerships
• Represent AZ Externally: Represent AZ at external partner meetings (appropriate flexibility regarding regions/time zones may be needed) where delegated by Regulatory Business Development Lead.
• Track Regulatory service: Working with the relevant functional leads, and Regulatory experts, develop, establish, monitor, report.
• Champion a culture of continuous improvement: monitor the current processes and evaluate the scope of continuous improvement. Propose opportunities for enhancement to existing processes and partnerships through knowledge of internal and external environment. Support the development and/or enhancement of standards or techniques to improve the quality, compliance and efficiency of deliverables for the overall group. Demonstrate a “can do” attitude, identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes and partnerships.
Support Inspection Readiness: Utilize regulatory knowledge to maintain and support the global inspection readiness strategy. Manage relationships/partnerships/alliances external to the AZ ORSSE function that are essential to delivering AstraZeneca’s regulatory responsibilities. Identify issues and risks and propose options to mitigate them. Ensure that appropriate, up-to-date records are maintained for compliance
• Management of deal agreements: Provide oversight of the Regulatory aspects of deals and the coordination and ownership of the management of new and existing partnerships and agreements. Champion communication and change management activities associated with processes and partnering initiatives
Last Date To Apply: 12th September 2022
Apply Online
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