Regulatory Manager

Job Description

HR Bamboos connects exceptional professionals with reputable organizations across Iran and international markets.

We are seeking a Regulatory Manager to join our client, a reputable pharmaceutical company. The selected candidate will act as the company's key representative in interactions with regulatory bodies, including the Food and Drug Administration, ensuring that all processes, standards, and products fully comply with legal requirements and quality standards.

Key Responsibilities
• Oversee the establishment and strict implementation of quality regulations and standards (GMP and GXP) across the organization.
• Prepare, review, and approve technical dossiers (CTD) for obtaining, renewing, or amending pharmaceutical licenses.
• Maintain continuous interaction, follow-up, and defense of the company's dossiers with the Food and Drug Administration and other regulatory bodies.
• Lead and fully manage the product recall process in the event of quality deviations.
• Continuously evaluate suppliers and monitor the quality of raw materials and packaging based on pharmaceutical requirements.
• Supervise quality management systems and operational documents, and address any potential deviations.
• Train and raise the awareness of the organization's staff regarding regulatory laws and standards.

What You Bring
• Minimum of 10 years of specialized experience in regulatory affairs and pharmaceutical industry laws.
• Doctorate degree in Pharmacy (or closely related fields).
• Comprehensive mastery of GXP, GMP standards, and Food and Drug Administration regulations.
• High proficiency in compiling, structuring, and defending Common Technical Documents (CTD).
• Excellent abilities in risk assessment, resolving discrepancies, and managing quality crises.
• Strong communication skills with the ability to interact effectively with government bodies and external auditors.
• Solid understanding of documentation principles and Data Integrity.

Nice To Have
• Full professional proficiency in English for conducting detailed reviews of reference texts (such as WHO, PIC/S).
• Experience working with Quality Management System (QMS) software.

What We Offer
• Supplementary insurance
• Company doctor
• Bonus
• Loan

We look forward to reviewing your application.

Apply now

We maintain the highest level of confidentiality throughout the recruitment process.