Job Description

JOB TITLE: REGULATORY AFFAIRS MANAGER I

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 ASTRAZENECA

At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s 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 I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned results, including delivery as an individual contributor, if required.

The Regulatory Affairs Manager I is fully proficient in applying established standards to perform regulatory affairs management for simple/moderately complex products/regions and under minimal supervision. 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 to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Provides regulatory labeling expertise and leads the maintenance of labeling documents for allocated products. Is responsible for the regulatory activities involved in the coordination, development and implementation of revised printed labeling for allocated products and other regional labeling.

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 and all application types per market and /or region.

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

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.

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.

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

Develops, completes and maintains submission delivery plans, submission content plans, and proactively provides status updates to designated collaborators.

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 results, including generating work requests and submission content plans, submission tracking, TMF, and document management applying the support and input of Global Regulatory Operations, Marketing Companies, CROs and/or alliance partners where relevant.

Ensures that appropriate, up-to-date records are maintained for compliance, including maintaining repositories of current regional labeling and ensuring proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents,.

Provides coaching, mentoring and knowledge sharing within the regulatory organisation.

Contributes to process improvement.

Minimum Requirements \xe2\x80\x93Education and Experience

Relevant University Degree in Science or related field

Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets General knowledge of drug development

Good knowledge of the regulatory product maintenance process

Strong project management skills

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

Handled regulatory deliverables at the project level

Experience of working with people from locations outside of India, especially Europe and/or USA

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 collaborator management skills

Ability to analyze problems and recommend actions

Continuous Improvement and knowledge sharing focused

Internal and External Contacts/Customers

Global Regulatory Leads (GRLs)

Regulatory Regional Leads (eg, US, EU, International RADs)

Lead RPM

Other R & D skill groups, eg, Global Regulatory Operations, Global Labelling Group, Operations Regulatory, Patient Safety

Operations/Manufacturing organisation (CMC post approval)

Marketing Companies/Local affiliates

Health Authorities

External collaboration partners

Reporting Relationship

Direct Reports - None

Indirect Reports -None

Office Working Requirements

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That\xe2\x80\x99s why we work, on average, a minimum of three days per week from the office. But that doesn\xe2\x80\x99t mean we\xe2\x80\x99re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

SO, WHAT\xe2\x80\x99S NEXT?

Are you already imagining yourself joining our team? Good, because we can\xe2\x80\x99t wait to hear from you.

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it\xe2\x80\x99s yours.

If you\xe2\x80\x99re curious to know more then please click the link to apply and we\xe2\x80\x99ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn:

Inclusion & Diversity:

Career Site:

Date Posted 16-Nov-2023

Closing Date 23-Nov-2023

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.

AstraZeneca