Regulatory Affairs Manager I

2 weeks ago

Bangalore, India AstraZeneca Full time

Job Title: Regulatory Affairs Manager I

Career Level - D

Introduction to Role:
Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a role that offers the opportunity to contribute to our drug development strategies and turn them into reality. As a regulatory specialist with project management capabilities, you will be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. This role offers the chance to work flexibly across various roles within a Global Regulatory Execution Team (GRET), including Regulatory Affairs Management, Global Labelling Management, and Dossier Management. 

Accountabilities:
As a Regulatory Affairs Manager I, you will contribute to regulatory submission strategy, identifying submission risks and opportunities while leading simple through more complex regulatory applications and managing procedures through approval. You will provide regulatory expertise and guidance on procedural and documentation requirements to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams. You will also be responsible for the regulatory activities involved in the coordination, development and implementation of revised printed labeling for allocated products. In addition, you will plan and manage Regulatory and basic Clinical and Non-Clinical publishing deliverables, as well as associated lifecycle and license information.

Essential Skills/Experience:
- Relevant University Degree in Science or related discipline
- Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry
- Thorough knowledge of the regulatory product maintenance process
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
- Excellent English written and verbal communication skills
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Proficiency with common project management (, MS Project) and document management tools
- Ability to work independently and as part of a team


While not essential, previous experience managing regulatory deliverables at the project level and working with people from locations outside of India, especially Europe and/or USA, would be beneficial.

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.

At AstraZeneca, we are committed to pushing beyond the traditional regulatory mindset. Innovation is at our heart, and we think broadly about patients and what it takes to prevent and treat diseases. We value our team's influential work in shaping drug development and gaining fast, efficient approvals. 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.

Join us today Be part of a dynamic team that's empowered to make quick decisions, operate independently but know how to influence and work well with others. Be supported to progress and develop fast. We are working towards our aspiration to make AstraZeneca the place to build a career in Regulatory. Here we inspire and support you to help drive your professional and personal growth and development. With a defined career ladder, a recognition culture that celebrates successes, and exciting opportunities for those with the drive to achieve. Are you ready to take the next step in your career? Apply now

Date Posted

06-Jun-2024

Closing Date

12-Jun-2024

  • Regulatory Affairs Manager I

    2 months ago

    bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...

  • Regulatory Affairs Manager I

    3 weeks ago

    bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...

  • Regulatory Affairs Manager I

    2 weeks ago

    bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a role that offers the opportunity to contribute to our drug development strategies and turn them into reality. As a regulatory specialist with project management capabilities, you will be...

  • Regulatory Affairs Associate I

    2 weeks ago

    Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Associate I Career Level - C Introduction to Role: Join our International Regulatory Affairs Management (RAM) team as a Regulatory Affairs Associate I. This role is an exciting opportunity to contribute to the development and approval of life-changing medicines for patients in international markets. As a Regulatory...

  • Associate Regulatory Affairs Director I

    4 weeks ago

    Bangalore, India AstraZeneca Full time

    Job Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business...

  • Associate Regulatory Affairs Director I

    4 weeks ago

    bangalore, India AstraZeneca Full time

    Job Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and...

  • Regulatory Affairs Manager II

    2 weeks ago

    Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager II (International Regulatory Affairs) Career Level - D Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to...

  • Regulatory Affairs Manager II

    2 weeks ago

    Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager II  Career Level - D Introduction to Role: Join our International Regulatory Affairs team at AstraZeneca, where we are committed to bringing life-changing medicines to patients in international markets as efficiently and effectively as possible. We have an exciting opportunity for a Regulatory Affairs Manager...

  • International CMC Regulatory Affairs Associate Director I

    2 weeks ago

    Bangalore, India AstraZeneca Full time

    Job Title: International CMC RA Associate Director I Career Level - E Introduction to Role: Join us at AstraZeneca as an International CMC RA Associate Director and play a critical role in impacting patients in need. In this role, you will have the opportunity to utilize your expertise in CMC Regulatory Strategy, Operational, tactical, and...

  • International CMC Regulatory Affairs Associate Director I

    7 days ago

    bangalore, India AstraZeneca Full time

    Job Title: International CMC RA Associate Director I Career Level - E Introduction to Role: Join us at AstraZeneca as an International CMC RA Associate Director and play a critical role in impacting patients in need. In this role, you will have the opportunity to utilize your expertise in CMC Regulatory Strategy, Operational, tactical, and...

  • Regulatory Affairs Manager

    3 weeks ago

    bangalore, India AstraZeneca Full time

    About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Position purpose For assigned...

  • Regulatory Affairs Manager

    3 weeks ago

    Bangalore, India AstraZeneca Full time

    About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Position purpose For assigned products:...

  • iCMC Regulatory Affairs Manager

    5 days ago

    Bangalore, India AstraZeneca Full time

    Job Title: iCMC Regulatory Affairs Manager Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as an iCMC Regulatory Affairs Manager. This is an exciting opportunity to innovate in a safe environment, where you will be part of a team with deep specialist knowledge and regulatory expertise. We are confident in what we know...

  • Manager Global Regulatory Affairs

    3 weeks ago

    bangalore, India Biocon Biologics Full time

    Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INBIOCON BIOLOGICSBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation,...

  • Manager Global Regulatory Affairs

    2 weeks ago

    bangalore, India Biocon Biologics Full time

    Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INBIOCON BIOLOGICSBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation,...

  • Regulatory Affairs Associate I

    2 months ago

    bangalore, India Teva Pharmaceuticals Full time

    Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...

  • Manager Global Regulatory Affairs

    3 weeks ago

    bangalore, India Biocon Biologics Full time

    Manager – Global Regulatory Affairs Location – Head-Office, Bangalore, IN BIOCON BIOLOGICS Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable...

  • Lead - Regulatory Affairs

    3 weeks ago

    bangalore, India Indegene Full time

    Title: Lead - Regulatory Affairs Date: May 10, 2024 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain...

  • Regulatory Affairs Operations Analyst

    1 day ago

    bangalore, India Lifelancer Full time

    About the job Job Description Summary This position is responsible for the creation, identification, collection, and entry of regulatory affairs information of medical devices. Support related regulatory affairs activities, such as assessment, execution and management of regulatory data and information to support all regulatory needs and objectives of...

  • Regulatory Affairs Administrative Assistant

    2 weeks ago

    bangalore, India ResMed Full time

    Summary: A Regulatory Affairs Administrative Assistant provides essential support to regulatory affairs professionals in managing compliance, documentation, and administrative processes. They play a crucial role in ensuring smooth operations within the regulatory department. Responsibilities and Accountabilities: Document Management: Assist in...