Advanz Pharma Hiring in Regulatory Affairs
Position: Specialist Regulatory Operations & Compliance (xEVMPD)
Organization: ADVANZ PHARMA
Qualification: B.Sc, M.Sc, B.Pharm, M.Pharm, Life Sciences
Experience: 1 – 4 Years
Salary: ₹4.8 Lakhs to ₹7.9 Lakhs per year
Location: Andheri, Mumbai (Hybrid working opportunity)
Key Responsibilities
- Lead xEVMPD/IDMP submissions ensuring quality standards and deadlines are met.
- 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 to 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
| Skill/Experience | Description |
|---|---|
| xEVMPD Submissions | Significant experience with xEVMPD submissions and EMA gateway maintenance. |
| Regulatory Systems | Hands-on experience with regulatory systems validation and implementation for xEVMPD/ISO IDMP. |
| Submission Requirements | Knowledge of global electronic submission requirements. |
| Document Management | Familiarity with electronic Document Management Systems like Veeva Vault RIM. |
| Regulatory Guidelines | Understanding of ICH and regional regulatory guidelines. |
| Project Management | Strong project management and communication skills. |
| Collaboration | Collaborative and solution-oriented mindset. |
| Work Environment | Ability to work in a fast-paced, agile environment. |
| Attitude | 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.