Job Description
Regulatory Affairs Executive | Regulatory Affairs | Hetero | Hyderabad, Telangana, India
Hetero is hiring qualified professionals for the role of Regulatory Affairs Executive for its pharmaceutical regulatory operations located in Hyderabad, Telangana, India. This full-time opportunity is suitable for candidates having 3 to 7 years of experience in API regulatory affairs, pharmaceutical documentation, regulatory compliance, dossier preparation, submission management, audit coordination, GMP systems, product registration activities, quality documentation, and regulatory lifecycle management within pharmaceutical manufacturing environments.
The selected candidate will support regulatory affairs operations related to API products while ensuring compliance with global pharmaceutical regulations and internal quality standards. Responsibilities include preparing and reviewing regulatory dossiers and technical documentation, coordinating with quality assurance and production teams, supporting regulatory submissions and product registration activities, maintaining compliance records and documentation systems, ensuring adherence to GMP and regulatory guidelines, participating in audit preparation and inspection support activities, monitoring regulatory updates and compliance requirements, handling variation and amendment documentation, supporting customer and authority queries related to regulatory affairs, and contributing to continuous improvement initiatives related to pharmaceutical regulatory systems. Candidates should possess strong knowledge of API regulatory affairs operations and documentation management systems.
This role offers valuable exposure to pharmaceutical regulatory operations, API compliance systems, dossier preparation workflows, audit coordination activities, global regulatory standards, and regulated pharmaceutical environments within a reputed pharmaceutical company. Professionals interested in pharmaceutical regulatory affairs and compliance management can strengthen their technical and documentation expertise through this opportunity.
Location
Hyderabad, Telangana, India
Employment Type
Full-time
Experience Required
3 to 7
About Hetero
Hetero operates in the pharmaceutical industry specializing in API manufacturing, pharmaceutical development, regulatory compliance systems, and global healthcare product solutions.
Key Responsibilities
Prepare and review regulatory documentation and dossiers.
Support API regulatory submissions and registrations.
Coordinate with quality and production departments.
Maintain compliance records and documentation systems.
Ensure adherence to GMP and regulatory guidelines.
Participate in audits and inspection support activities.
Monitor regulatory updates and compliance requirements.
Handle variation and amendment documentation.
Support authority and customer regulatory queries.
Assist in continuous improvement of regulatory systems.
Required Skills
Knowledge of API regulatory affairs systems.
Understanding of pharmaceutical compliance workflows.
Awareness of dossier preparation and submissions.
Documentation and reporting expertise.
Problem-solving and analytical abilities.
Communication and coordination skills.
Time management and operational planning.
Attention to compliance accuracy and documentation quality.
Adaptability to pharmaceutical regulatory environments.
Strong understanding of GMP and global regulations.
Educational Qualification
B.Pharm
Industry
Pharmaceutical
Why Join Hetero?
Hetero offers professionals opportunities to work in globally regulated pharmaceutical environments with exposure to API regulatory systems and compliance operations.
How to Apply
Interested candidates can apply through ACKJOBS for this pharmaceutical regulatory affairs opportunity.
Check our website — www.ackjobs.com — regularly for the latest updates in the job market. Join our WhatsApp and social media groups from the website.
Hetero is hiring qualified professionals for the role of Regulatory Affairs Executive for its pharmaceutical regulatory operations located in Hyderabad, Telangana, India. This full-time opportunity is suitable for candidates having 3 to 7 years of experience in API regulatory affairs, pharmaceutical documentation, regulatory compliance, dossier preparation, submission management, audit coordination, GMP systems, product registration activities, quality documentation, and regulatory lifecycle management within pharmaceutical manufacturing environments.
The selected candidate will support regulatory affairs operations related to API products while ensuring compliance with global pharmaceutical regulations and internal quality standards. Responsibilities include preparing and reviewing regulatory dossiers and technical documentation, coordinating with quality assurance and production teams, supporting regulatory submissions and product registration activities, maintaining compliance records and documentation systems, ensuring adherence to GMP and regulatory guidelines, participating in audit preparation and inspection support activities, monitoring regulatory updates and compliance requirements, handling variation and amendment documentation, supporting customer and authority queries related to regulatory affairs, and contributing to continuous improvement initiatives related to pharmaceutical regulatory systems. Candidates should possess strong knowledge of API regulatory affairs operations and documentation management systems.
This role offers valuable exposure to pharmaceutical regulatory operations, API compliance systems, dossier preparation workflows, audit coordination activities, global regulatory standards, and regulated pharmaceutical environments within a reputed pharmaceutical company. Professionals interested in pharmaceutical regulatory affairs and compliance management can strengthen their technical and documentation expertise through this opportunity.
Location
Hyderabad, Telangana, India
Employment Type
Full-time
Experience Required
3 to 7
About Hetero
Hetero operates in the pharmaceutical industry specializing in API manufacturing, pharmaceutical development, regulatory compliance systems, and global healthcare product solutions.
Key Responsibilities
Prepare and review regulatory documentation and dossiers.
Support API regulatory submissions and registrations.
Coordinate with quality and production departments.
Maintain compliance records and documentation systems.
Ensure adherence to GMP and regulatory guidelines.
Participate in audits and inspection support activities.
Monitor regulatory updates and compliance requirements.
Handle variation and amendment documentation.
Support authority and customer regulatory queries.
Assist in continuous improvement of regulatory systems.
Required Skills
Knowledge of API regulatory affairs systems.
Understanding of pharmaceutical compliance workflows.
Awareness of dossier preparation and submissions.
Documentation and reporting expertise.
Problem-solving and analytical abilities.
Communication and coordination skills.
Time management and operational planning.
Attention to compliance accuracy and documentation quality.
Adaptability to pharmaceutical regulatory environments.
Strong understanding of GMP and global regulations.
Educational Qualification
B.Pharm
Industry
Pharmaceutical
Why Join Hetero?
Hetero offers professionals opportunities to work in globally regulated pharmaceutical environments with exposure to API regulatory systems and compliance operations.
How to Apply
Interested candidates can apply through ACKJOBS for this pharmaceutical regulatory affairs opportunity.
Check our website — www.ackjobs.com — regularly for the latest updates in the job market. Join our WhatsApp and social media groups from the website.