Regulatory Affairs - Post Deal Operations Manager I/II

Job Title: Regulatory Affairs - Post Deal Operations Manager I/II

Career Level - D

Job Description

The  Regulatory Affairs Manager 1 with Business Development 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 role comprises of two main accountabilities, described below.

As a member of the Late Cardiovascular, Renal and Metabolism (CVRM) regulatory team, the role holder will work with the Project Director in Regulatory Business Development;  supporting out Licensing deals, both with the transition work and the regulatory maintenance of licences prior to transfer.  During the transition phase the Post Deal Operations Manager  (PDOM)  should ensure that all regulatory milestones in the Transition Service Agreements (TSA), are achieved,  whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e., Licensing Partners, Outsourcing Partners).

The (PDOM) will take accountability for providing regulatory support to those projects who are going through a long transition timeline. As such the PDOM will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required.

Regulatory Business Development role:

Work closely with a broad cross-functional core transition team, comprised of functional representatives appropriate for the deal. As Post Deal Operations Manager (PDOM) for Regulatory Affairs (RA) you will manage 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 operational activities including but not limited to: running the green light process, preparation of documentation and regulatory activities.

The PDOM will collaborate with the equivalent external deal partner counterpart to deliver the agreed ways of working for the joint workstream team, and engage in regular status issue and risk discussions, to ensure smooth transitions.

Regulatory Affairs Management

Contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through to approval. Provides regulatory expertise and guidance on procedural and documentation requirements to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Regulatory Business DevelopmentAccountabilities/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 Project SPOL or BOX site, 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.

• 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 ERV, and documents uploaded to CARA as required.

• Draft and ensure review and completion of regulatory documentation required for 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.

• Champion a culture of continuous improvement: monitor the current processes and partnerships and look for opportunities for improvement. 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 Late CVRM 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.

RAM Accountabilities/Responsibilities

• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.

• Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:

  • Review of documents (e.g. response documents, study protocols, regulatory maintenance documents, PSRs, etc.).

  • Submission delivery strategy of all dossiers and all application types per market and /or region.

• Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.

• Uses and shares 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.

• 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.

• 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.

Education, Qualifications, Skills and Experience Essential

• A science/pharmacy/nursing degree, with at least 4 years relevant experience (pharmaceutical, regulatory, and partnership)

• Experience in working cross-functionally

• Thorough scientific knowledge sufficient to understand all aspects of regulatory/ and partnership issues

• Good understanding 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

• Abletowork 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 Late CVRM 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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

At AstraZeneca's Biopharmaceuticals R&D division, you'll play a critical role in impacting patients in need. Our science-led enterprise is constantly developing new, complex products to get to market. We drive fast approvals to play an instrumental role in achieving our aim of getting the right medicines to the right patients, faster than ever before. It's meaningful to be part of AstraZeneca's growth and deliver life-changing medicines to patients in areas of unmet medical needs.

We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next. Part of a dynamic team, we're empowered to make quick decisions. We can operate independently but know how to influence and work well with others. Trusted and respected, we're often called upon to provide input in shaping drug development strategy across all levels of the business.

Are you ready to make a difference? Apply today and join us in our mission to deliver life-changing medicines!

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.