Regulatory Affairs Manager I/II

📍India – Bangalore

JOB TITLE: Regulatory Affairs Manager I/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 THE ROLE

The Regulatory Affairs Manager I/II in the Regulatory Business Development Post Deal Management group is a regulatory specialist with project management capabilities responsible for both regulatory life cycle maintenance submissions and managing successful application transitions for products that are either divested or acquired. The Regulatory Affairs Manager I /II will be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required. The Regulatory Affairs Manager I /II will take on the accountabilities for two different roles: the first as a Regulatory Transition Lead in the Post Deal operation group and the second as a Regulatory Affairs Manager within a Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager I/II is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their line manager or by the Lead Regulatory Project Manager (RPM) for their allocated GRET(s).

The Regulatory Affairs Manager I/II is fully proficient in applying established standards to perform regulatory affairs management for simple/moderately sophisticated products/regions and under minimal direction and is capable of leading cross functional activities. The Regulatory Transition Lead will lead cross-functional teams to ensure that licences for either clinical or commercial drug products are transferred either into or out from AstraZeneca in a timely manner with no impact to patients. Both roles require active participation in the continuous improvement of process and tools/systems.

Regulatory Affairs Management

Contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more sophisticated 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 whilst working flexibly within and across regions to ensure the successful delivery of business objectives.

Regulatory Transition Lead

Work closely with a cross-functional core transition team, comprised of both internal and external representatives appropriate for the deal. Accountable for regulatory transition activities to achieve relevant project turning points, as well as core business development operational activities including but not limited to running the green light process, preparation of documentation and risk / issue management. Collaborate with the equivalent external deal partner counterpart to deliver the agreed ways of working for the joint workstream team, and engage in regular issue and risk discussions, to ensure smooth transitions.

Accountabilities/Responsibilities:

Regulatory Affairs Management

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

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 Experience

Relevant 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 Experience

Regulatory 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 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.

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.