Regulatory Affairs

Job Details

* Company: Hetero
* Position: Regulatory Affairs – Formulation
* Department: Regulatory Affairs
* Location: Jeedimetla, Hyderabad
* Market Exposure: Middle East & GCC Countries
* Qualification: B.Pharm / M.Pharm
* Experience: 8–14 Years
* Employment Type: Full-Time

🌍 Career Opportunity | Regulatory Affairs – Formulation (Middle East & GCC Markets)

Advance your career with an exciting opportunity in Regulatory Affairs – Formulation. We are seeking experienced regulatory professionals with expertise in Middle East & GCC markets to support global pharmaceutical product registrations, regulatory compliance, and lifecycle management.

Key Responsibilities

* Prepare, review, and submit regulatory dossiers for Middle East & GCC markets.
* Manage product registrations, renewals, variations, and lifecycle management activities.
* Handle pre-approval and post-approval regulatory submissions.
* Prepare and maintain CMC documentation in line with regional regulatory requirements.
* Coordinate MAA submissions and ensure compliance with country-specific regulations.
* Develop and implement regulatory strategies to support product approvals and market expansion.
* Collaborate with cross-functional teams to ensure timely regulatory deliverables.

Required Skills

* Strong expertise in Middle East & GCC regulatory requirements.
* Hands-on experience with dossier preparation, product registrations, and lifecycle management.
* Thorough understanding of CMC documentation and regulatory compliance.
* Experience in MAA submissions and regional regulatory strategies.
* Excellent analytical, documentation, and communication skills.
* Ability to work effectively with cross-functional teams in a global regulatory environment.

Disclaimer: FYND Talent Solutions is an independent recruitment platform. This job is shared for informational purposes only and is not an official communication from the hiring company unless explicitly stated.

Apply Now-chandrasekhar.r@hetero.com

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