Regulatory Affairs Specialist

**Regulatory Affairs Specialist**

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 accelerate Regulatory approvals for new medicines in International markets as efficiently and effectively as possible so that no patient waits.

**Accountabilities/Responsibilities**:

- Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
- Maintain documentation & records management in Veeva RIM system in accordance with defined standards & process and as requested by RAMs eg. support with Submission Ready standards/Housestyle skills & QA checks, specific authoring tasks
- Input regulatory knowledge, intelligence & information into relevant systems and databases maintaining data accuracy and up to date information for the group and relevant databases and platforms.
- 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. CPP ordering. 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, requesting authentication of documents, 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 guidance and knowledge sharing within the RAM skill group
- Contribute to process improvement

**Minimum Requirements**:

- Relevant qualification and/or experience in science
- Regulatory experience from biopharmaceutical industry, or other relevant experience
- Some regulatory/medical/technical experience
- Knowledge of AZ business and processes
- Knowledge of AZ submissions, compilation, publishing and approval processes, standards, systems and tools
- Good written and verbal communication skills
- Experience of working with people from locations outside of India, especially from International Regions
- Good commercial and product awareness

**Skills & Capabilities**:

- Good Communication and influencing skills
- Good IT/IS skills
- Project planning and organisational skills - Focus on delivery and results
- Flexibility and adaptability
- Interpersonal and networking skills
- Independent and Team working
- Proactivity
- Problem solving

**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, Reg TA (GRL & Regional Leads)
- Marketing Companies
- Health Authorities
- External collaboration partners
- AstraZeneca Legal

**Reporting Relationship**:

- Direct Reports - None
- Indirect Reports -None