Latest Pharma Jobs 2025
Apply for Sante Jobs 2025 as Senior Assistant Manager International Regulatory Affairs. Pharm-D or M.Pharm with 4–6 years’ regulatory experience required.
Senior Assistant Manager – International Regulatory Affairs
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Job Responsibilities
Prepare, review, and submit regulatory documentation to international bodies.
Ensure timely submission of dossiers, renewals, and variation applications.
Stay updated with regulations in export markets and guide factory operations.
Support international authority inspections at the factory.
Maintain readiness in documentation and regulatory query responses.
Evaluate regulatory impact of changes in manufacturing, packaging, or analytical methods.
Submit timely variations to concerned authorities.
Maintain updated records of dossiers, certificates, and correspondence.
Prepare status reports for ongoing and planned submissions.
Eligibility
Education:
Pharm-D or M. Pharm
Certifications in International Regulatory Compliance (preferred)
Experience:
4–6 years in regulatory affairs (focus on export markets preferred)
Skills:
Excellent written and verbal communication skills
Proficiency in Microsoft Office and document management tools
Regulatory knowledge and technical expertise
Problem-solving and decision-making
Sante Private Limited is offering a career opportunity for professionals as Senior Assistant Manager – International Regulatory Affairs. This role is ideal for candidates with a Pharm-D or M. Pharm, plus 4–6 years of experience in regulatory compliance with a focus on export markets.
The position involves preparing regulatory submissions, ensuring compliance with international standards, and supporting inspections. With excellent career growth and opportunities in pharmaceutical exports, this is a strong opening for experienced professionals. Eligible candidates are encouraged to apply through Sante HR/career portal at the earliest.
Q1: What is the position announced at Sante Private Limited?
The announced position is Senior Assistant Manager – International Regulatory Affairs.
Q2: What education is required?
Pharm-D or M. Pharm, with preference for those having certifications in International Regulatory Compliance.
Q3: How much experience is needed for this job?
Applicants must have 4–6 years of experience in regulatory affairs, preferably in export markets.
Q4: What are the main responsibilities of this role?
The role includes preparing and submitting regulatory dossiers, managing renewals, guiding on international compliance, and supporting inspections.
Q5: What skills are required for this job?
Strong communication, MS Office proficiency, regulatory knowledge, problem-solving, and decision-making skills.
