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.
A fantastic permanent opportunity has now arisen for a Regulatory Affairs Specialist to join our International Regulatory Affairs Management (RAM) team. The Regulatory Affairs Specialist assists other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards. The Regulatory Affairs Specialist is an individual contributor and active team contributor who applies regulatory knowledge, may work under limited supervision, and participates in... continuous improvement of process and tools/systems.
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
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Date Posted
03-abr-2024
Closing Date
21-abr-2024
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
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