International Regulatory Affairs Manager

AstraZeneca · Petaling Jaya

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JOB TITLE: Regulatory Affairs Manager II, International Regulatory Affairs

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

Description:

The Regulatory Affairs Manager II in International Regulatory Affairs is 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. The Regulatory Affairs Manager II in International Regulatory Affairs will be responsible for tactical delivery of Int’l Marketing Authorisation Applications (MAAs) and Clinical Line Extensions (CLEs within an assigned Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager II is expected to be able to work flexibly to deliver these 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 II is fully proficient in applying established standards. Performs Regulatory Affairs Management for highly complex International market submissions under minimal supervision. May facilitate strategic input, capable of leading cross functional activities. Capable of leading cross functional activities. Participates 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 complex regulatory applications and managing procedures through approval. Provides regulatory expertise and guidance on procedural and documentation requirements for International markets to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

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 for MAA and CLE dossiers market and /or region.

  • Contribute to and review of response documents

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

• 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.

• Liaises closely with cross-functional team members with aligned product responsibilities.

• Develops, executes and maintains submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.

• Coordinates the input and revision of project plans for assigned projects and highlights unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.

• Identifies regulatory risks and propose 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, utilizing the support and input of Global Regulatory Operations, Marketing Companies, CROs and/or alliance partners where relevant.

• Provides coaching, mentoring and knowledge sharing on International markets within the regulatory organisation.

• Contributes to process improvement.

Minimum Requirements –Education and Experience

• Relevant University Degree in Science or related discipline

• Minimum 8 years of relevant Regulatory experience within the biopharmaceutical industry,

• General knowledge of drug development

• Strong project management skills

• Knowledge of the Regulatory new MAA roll-out process

• Knowledge of International markets in some or all Int’l regions

• Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience

• Regulatory affairs experience across a broad range of markets

• Having experience in Regulatory Information Management system (RIM)

• Managed regulatory deliverables at the project level

• Experience of working with people from locations outside of India, especially in the International regions.

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

• Ability to work independently and as part of a team 

• Influencing and stakeholder 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

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.

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