Regulatory Affairs Assistant at ACG
A rare chance has emerged at ACG for the position of Assistant in Regulatory Affairs. This ACG regulatory affairs job is located in Kandivali, India, and offers an opportunity to contribute to regulatory compliance and support for pharmaceutical products. Interested candidates are encouraged to apply before the deadline.
About The Company
ACG is the world’s only integrated pharma manufacturing solutions company, headquartered in Mumbai, India. With a presence in over 100 countries, ACG provides world-class technology across multiple domains, offering a complete range of solutions that include empty capsules, granulation, tablet coating, capsule filling, and packaging solutions.
Job Details
- Company: ACG
- Location: Kandivali, India
- Position Title: Assistant – Regulatory Affairs, ACG Capsules
- Department: Quality and Regulatory Affairs
- Reports to: Senior Lead – Regulatory Affairs, ACG Capsules
- Grade: M09
ACG Regulatory Affairs Job Description
The Assistant in Regulatory Affairs will provide regulatory support to customers, ensuring compliance with current and new regulatory norms. The role involves lifecycle management of existing dossiers across various countries to meet customer and regulatory standards.
Key Responsibilities
- Provide regulatory support to customers in order to meet current and new regulatory norms.
- Manage the lifecycle of existing dossiers in various countries.
- Ensure compliance with all regulatory norms (new & existing).
- Prepare & submit Drug Master Files in CTD format for respective regions.
- Handle customer questionnaires and specifications in a timely manner.
- Respond to customer and regulatory queries within pre-defined timelines.
- Conduct regulatory checks of shades & artwork.
- Obtain and renew regulatory certificates in a timely manner.
- Generate and maintain regulatory backup data.
- Provide regulatory support to Plant QA and International RA teams.
- Verify regulatory acceptance of various ingredients in different countries.
- Maintain and update data in internal online systems.
Eligibility for the ACG Regulatory Affairs Job
For this ACG regulatory affairs job, the candidate should possess relevant qualifications and experience in Regulatory Affairs or a related field.
Required Skills
- Strong understanding of regulatory norms and compliance.
- Excellent communication skills for customer interactions.
- Ability to manage multiple tasks and deadlines.
- Detail-oriented with strong analytical skills.
- Proficient in preparing regulatory documentation.
- Team player with the ability to work collaboratively.
- Familiarity with pharmaceutical industry standards.
- Proficient in data management and reporting.
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Additional Information
Any other additional responsibilities could be assigned to the role holder from time to time as standalone projects or regular work. The same would be suitably represented in the primary responsibilities and agreed upon between the incumbent, reporting officer, and HR.
The ACG regulatory affairs job for the Assistant – Regulatory Affairs position is a significant step for candidates looking to advance their careers in the pharmaceutical industry. Qualified individuals are encouraged to apply before the deadline to be part of a leading organization in integrated pharma manufacturing solutions.
