We are a leading global pharmaceutical organization committed to improving lives through innovative healthcare solutions. With a strong focus on research, development, and regulatory compliance, we strive to deliver high-quality products that meet global standards. Our team is dedicated to fostering a culture of excellence, collaboration, and continuous learning.
Job Description
Key Responsibilities:
As a Senior Regulatory Operations Specialist I, you will play a pivotal role in ensuring compliance with global regulatory requirements and supporting the lifecycle management of pharmaceutical products. Your responsibilities will include:
- Regulatory Documentation & Submissions:
- Prepare, compile, and review product quality (CMC) and other regulatory documents for global product registrations and post-approval maintenance.
- Support the creation and update of global labeling documents, ensuring compliance with content and format requirements.
- Change Control & Compliance:
- Coordinate with cross-functional teams to evaluate change controls, assess implementation strategies, and manage OOS, OOT, or product-related changes.
- Update and review packaging-specific documents, ensuring alignment with stakeholder requirements.
- Supplier & Packaging Management:
- Manage supplier agreements for new packaging development projects and commercial specification updates.
- Optimize existing packaging components under the guidance of the Packaging Development Engineer.
- Data Management & Reporting:
- Support stability data evaluation, dissolution profile analysis, and preparation of regulatory documents for APIs, excipients, and drug products.
- Perform literature searches to support regulatory submissions.
- Licensing & Compliance:
- Manage the submission and maintenance of Import/Export Licenses, Dual Use NOCs, and Import Certificates.
- Ensure timely license applications, availability, debiting, and reconciliation.
- Quality Assurance & Training:
- Perform quality checks, update internal and external trackers, and ensure compliance with regulatory guidelines.
- Assist in training and mentoring junior staff to foster a culture of continuous improvement.
- Strategic Coordination:
- Escalate potential issues and serve as an analytical strategist across product development and post-approval stages.
- Implement efficient and quality processes to meet regulatory timelines and deliverables.
Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- 5+ years of experience in regulatory operations, CMC, or pharmaceutical product lifecycle management.
- Strong knowledge of global regulatory guidelines (e.g., FDA, EMA, WHO).
- Proficiency in Computerized System Validation (CSV) and software upgrades.
- Excellent communication, organizational, and problem-solving skills.
- Ability to work collaboratively in a cross-functional team environment.
Why Join Us?
- Hybrid Work Model: Enjoy the flexibility of working remotely and in-office.
- Career Growth: Opportunities for professional development and advancement.
- Impactful Work: Contribute to the development of life-saving pharmaceutical products.
- Inclusive Culture: Be part of a diverse and supportive team.
How to Apply
If you are passionate about regulatory operations and want to make a difference in the pharmaceutical industry, we encourage you to apply!
Application Deadline: March 18, 2025
