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Regulatory Affairs Executive

Aurobindo Pharma

Hyderabad, Telangana

Department: Regulatory Affairs

Experience: 4-8 Years

Industry: Pharmaceutical

Education: M.Pharm

Remarks: EU market experience

Job Description

Job Description

Regulatory Affairs Executive | Aurobindo Pharma | Hyderabad, Telangana, India

Aurobindo Pharma is hiring experienced professionals for the role of Regulatory Affairs Executive for its pharmaceutical regulatory operations in Hyderabad, Telangana, India. This full-time opportunity is suitable for candidates with 4 to 8 years of experience in regulatory affairs, pharmaceutical documentation, dossier preparation, EU market compliance, regulatory submissions, pharmaceutical quality systems, product registration activities, compliance coordination, technical documentation management, and global pharmaceutical regulatory operations.

The selected candidate will support regulatory affairs and compliance activities related to pharmaceutical products and international market submissions. Responsibilities include preparing and reviewing regulatory dossiers and technical documents, coordinating with cross-functional departments for submission activities, supporting EU regulatory compliance requirements, maintaining product registration records and documentation systems, monitoring regulatory updates and pharmaceutical compliance guidelines, participating in audit preparation and compliance review discussions, coordinating with quality assurance and production teams, supporting variation filing and submission management activities, ensuring adherence to global regulatory standards and operational procedures, and contributing to continuous improvement initiatives related to regulatory documentation and pharmaceutical compliance systems.

This role offers valuable exposure to international pharmaceutical regulatory systems, EU market operations, dossier management workflows, global compliance standards, pharmaceutical quality systems, and regulatory coordination environments within a reputed pharmaceutical organization. Professionals interested in regulatory affairs and pharmaceutical compliance can strengthen their technical and documentation expertise through this opportunity.

Location
Hyderabad, Telangana, India

Employment Type
Full-time

Experience Required
4 to 8

About Aurobindo Pharma
Aurobindo Pharma operates in the pharmaceutical industry specializing in formulation manufacturing, global pharmaceutical operations, regulatory compliance systems, and healthcare product development.

Key Responsibilities

Prepare and review regulatory dossiers and submissions.
Support EU market regulatory compliance activities.
Coordinate with quality and production departments.
Maintain regulatory documentation and records.
Monitor compliance guidelines and regulatory updates.
Participate in audit and submission review activities.
Support product registration and variation filing operations.
Ensure adherence to global regulatory standards.
Maintain reporting and documentation systems.
Support continuous improvement in compliance workflows.


Required Skills

Knowledge of regulatory affairs and pharmaceutical compliance.
Understanding of EU market regulatory systems.
Awareness of dossier preparation and submission workflows.
Documentation and reporting expertise.
Problem-solving and coordination abilities.
Communication and compliance management skills.
Time management and workflow planning.
Attention to regulatory accuracy and standards.
Adaptability to global pharmaceutical environments.
Technical and compliance coordination expertise.


Educational Qualification
M.Pharm

Industry
Pharmaceutical

Why Join Aurobindo Pharma?
Aurobindo Pharma offers professionals opportunities to work in global pharmaceutical regulatory environments with exposure to international compliance systems and healthcare operations.

How to Apply
Interested candidates can apply through ACKJOBS for this pharmaceutical regulatory affairs opportunity.

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