As ADVANZ PHARMA continues to expand, we are looking for a Specialist in Regulatory Operations & Compliance to join our team. The role involves coordinating and managing xEVMPD/IDMP submissions, ensuring compliance with electronic submission standards, and supporting regulatory systems processes.
Key Responsibilities:
- Lead xEVMPD/IDMP submissions and ensure they meet quality standards and deadlines.
- Provide expertise on ISO IDMP Standards, EU Implementation Guide, and related regulatory requirements.
- Develop and implement new regulatory processes and improve existing ones.
- Ensure compliance with Electronic Document Management Systems and regulatory standards.
- Maintain and track progress of regulatory submissions and ensure timely submissions.
- Manage data migration, mapping, cleaning, and enrichment for IDMP.
- Participate in system validation and implementation projects.
- Train and support new users of regulatory systems.
Qualifications:
- Formal training in Regulatory Affairs.
- Graduate/Post-graduate in any discipline of science, preferably life sciences or pharmacy.
Experience and Skills:
- Significant experience with xEVMPD submissions and EMA gateway maintenance.
- Hands-on experience with regulatory systems validation and implementation for xEVMPD/ISO IDMP.
- Knowledge of global electronic submission requirements.
- Familiarity with electronic Document Management Systems like Veeva Vault RIM.
- Understanding of ICH and regional regulatory guidelines.
- Strong project management and communication skills.
- Collaborative and solution-oriented mindset.
- Ability to work in a fast-paced, agile environment.
- Positive attitude with a focus on continuous improvement and development.
Why ADVANZ PHARMA?
- Empowerment to take ownership and embrace challenges.
- Inclusive and respectful work environment.
- Commitment to gender equality and promoting from within.
- Recognition of talent through promotions and annual Impact Awards.
- Competitive salary and benefits package.
- Flexible, agile working options.