Regulatory Affairs Associate Ii

4 weeks ago

Bengaluru, India AstraZeneca Full time

**JOB TITLE: REGULATORY AFFAIRS ASSOCIATE II**:
**CAREER LEVEL: C**:
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**:
**Accountabilities/Responsibilities**:

- Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
- Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
- Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals.
- Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation
- Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser
- Provide coaching, mentoring and knowledge sharing within the RAM skill group
- Lead and contribute to process improvement

**Minimum Requirements -Education and Experience**
- Relevant qualification and/or experience in science
- Minimum 4 years of Relevant experience from biopharmaceutical industry, or other relevant experience
- Proficient verbal and written English
- Project Management skills
- Experience in document management and tracking databases

**Preferred Experience**
- Some regulatory/medical/technical experience
- Knowledge of AZ business and processes
- Some knowledge of AZ submission, compilation, publishing and approval processes, standards, systems and tools
- Experience of working with people from locations outside of India, especially Europe and/or USA

**Skills and Capabilities**
- Good written and verbal communication skills
- Cultural awareness
- Proficiency with common document management tools
- Ability to work independently and as part of a team
- 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?**

**WHERE CAN I FIND OUT MORE?**

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.

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