Regulatory Affairs Associate Ii

4 weeks ago

Bengaluru, India AstraZeneca Full time

**JOB TITLE: Regulatory Affairs Associate II**:
**CAREER LEVEL: C**:
**Leverage technology to impact patients and ultimately save lives**

**ABOUT ASTRAZENECA**:
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.

**ABOUT OUR IT TEAM**:
It’s a dynamic and results-oriented environment to work in - but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross
- functionally and broadly together.

**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.
- Contribute to EU-CP Linguistic review
- Provide guidance and knowledge sharing within the RAM skill group
- Contribute to process improvement
- Support GRET RAM and LRPM on any operational tasks
- Audit Support and Tender Support to GRET.
- Support proofreading request via TVT for Standard export pack labels etc.

**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

**Internal and External Contacts/Customers**
- Lead RPM and members of the GRET and GRST
- Other R&D skill groups, e.g., GRO, GLG, Reg CMC, Operations regulatory, PS, Regulatory Central, GRL & Regional Leads
- Marketing Companies
- Health Authorities
- External collaboration partners
- AstraZeneca Legal

**WHY JOIN US?**

We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.

We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.

**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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