As an Executive / Senior Executive in Regulatory Affairs, you will manage the life cycle of assigned products, ensuring compliance with EU regulations and other country-specific requirements. This role involves preparation, submission, and follow-up of regulatory documents, coordinating with internal and external stakeholders, and maintaining Orion’s regulatory systems.
Key Responsibilities:
- Manage product life cycle and ensure compliance with regulatory authorities.
- Prepare and submit renewals and variations for regulatory approvals.
- Address regulatory queries and obtain necessary approvals.
- Maintain up-to-date regulatory systems and archives.
- Coordinate with stakeholders for effective change implementation.
Qualifications:
- Bachelor’s/Master’s degree in Pharmacy.
- 4+ years of experience in Regulatory Affairs.
- Knowledge of EU regulations, ICH guidelines, and product lifecycle management.
- Experience in Formulations Development is a plus.
- Strong communication skills and proficiency in Microsoft Office.
What We Offer:
- Flexible working environment with a hybrid work policy.
- Opportunities for career growth in a global organization.
- A supportive team that values your strengths.
- Excellent work-life balance.
Application Deadline:
Submit your application by August 31, 2024. Please fill out the Candidate Information Form and send your updated CV to recruitmentindia@orion.fi.
