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Regulatory Affairs Manager
2 weeks ago
As part of our consultancy partnership with
THEA Pharma
, we are searching for an experienced
Regulatory Affairs Manager
who will play a key role in ensuring regulatory excellence, compliance, and smooth market access operations in Turkey.
Responsibilities
Near & Long-Term Goals:
- Lead all regulatory applications related to new product licensing and license maintenance/improvement for existing products, in alignment with local regulations and company procedures.
- Manage regulatory processes according to strategic business decisions on product licensing in Turkey.
- Coordinate and update SOPs, reports, presentations, launch tables, and regulatory databases.
- Monitor regulatory changes and ensure full compliance.
- Support the Responsible Pharmacist and Qualified Scientific Person in quality, market access, business compliance, and pharmacovigilance.
- Oversee GMP-related activities: organizing audits, accompanying auditors, and ensuring timely issuance of GMP certificates.
- Handle license and GMP renewals, Type I/II variations, artwork changes, SmPC-PIL updates, deficiency responses, and approval processes.
- Manage business compliance duties.
- Follow up on quality-related issues stemming from pharmacovigilance reports.
- Support cost-effectiveness studies and budget impact models for new product launches.
Requirements
- Bachelor's degree in Pharmacy
- Advanced level of written and spoken English
- Proficiency in MS Office applications
- (For male candidates) Completed military service
- 7–8 + years of experience in Regulatory Affairs
Skills
- Strong organizational and planning abilities
- Effective communication skills
- Problem-solving capability
- Technical expertise in regulatory processes
- Project management skills
- High attention to detail
- Commitment to ongoing learning about industry regulations
- Strong time management
- Willingness to travel
