Keuro Life - Manager - Regulatory Affairs - Pharma Domain

Job Description - Regulatory Affairs Manager (Pharma)

Company : Keuro Life LLP

Location: Chennai, India

Experience : Minimum 10 years

Industry : Pharmaceuticals

Regulatory Expertise : SFDA (Saudi Food & Drug Authority)

Role Overview :

- We are seeking a highly skilled and experienced Regulatory Affairs Manager to oversee and manage regulatory activities for pharmaceutical products, ensuring compliance with Saudi Food & Drug Authority (SFDA) regulations. The ideal candidate will be responsible for developing regulatory strategies, handling submissions, and ensuring timely approvals for pharmaceutical products intended for the Saudi Arabian market.

Key Responsibilities:

- SFDA Compliance & Submissions: Ensure all regulatory submissions, approvals, and renewals comply with SFDA guidelines for pharmaceutical products.

- Regulatory Strategy: Develop and implement regulatory strategies to facilitate product registrations, variations, and lifecycle management in the Saudi market.

- Dossier Preparation & Review: Prepare, review, and submit high-quality regulatory dossiers in eCTD format for new drug applications, generics, and renewals.

- Liaison with Authorities: Act as the primary point of contact with SFDA and other regulatory bodies, addressing queries and facilitating approvals.

- Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, Manufacturing, and Commercial teams to ensure regulatory compliance throughout product development and commercialization.

- Regulatory Intelligence: Monitor and interpret changes in Saudi regulatory requirements, updating internal stakeholders and ensuring timely compliance.

- Labeling & Packaging Compliance: Ensure that all product labeling, packaging, and promotional materials meet SFDA guidelines.

- Audit & Inspection Support: Prepare and assist in regulatory audits and inspections by SFDA and other relevant authorities.

- Product Lifecycle Management: Handle post-approval changes, renewals, and regulatory

variations efficiently.

Key Requirements:

- Experience: Minimum 10 years in Regulatory Affairs within the pharmaceutical industry.

- SFDA Expertise: Strong experience in Saudi regulatory requirements, submission procedures, and compliance with SFDA guidelines.

- Education: Bachelors/Masters degree in Pharmacy, Life Sciences, or a related field.

- Technical Skills: Proficiency in eCTD submission, dossier preparation, and regulatory documentation.

- Communication: Strong interpersonal and communication skills to liaise effectively with SFDA and internal teams.

- Regulatory Intelligence: Knowledge of international regulatory frameworks (e.g., FDA, EMA) is a plus.

Preferred Qualifications:

- Experience in handling biologics, generics, or OTC drugs.

- Prior experience in regulatory submissions for GCC markets.

- Understanding of Good Manufacturing Practices (GMP) and Quality Management Systems (QMS).

Why Join Us?

- Opportunity to work in a dynamic and growing pharmaceutical company.

- Challenging role with high visibility and strategic impact.

- Competitive compensation and benefits package.

If you meet the above criteria and are passionate about regulatory affairs in the pharmaceutical industry, we invite you to apply!