Octavius Pharma Pvt. Ltd., a growing pharmaceutical manufacturing company, is hiring a Regulatory Affairs Officer for its operations in Ahmedabad, Gujarat. This opportunity is ideal for pharmacy graduates who have experience in regulatory documentation, CTD dossier preparation, and coordination with cross-functional teams.
The company works across multiple pharmaceutical segments including tablets, capsules, injectables, nutraceuticals, herbal products, cosmetics, and finished formulations, and also provides services such as technology transfer, dossier preparation, and third-party manufacturing.
Job Details
Company
Octavius Pharma Pvt. Ltd.
Position
Regulatory Affairs Officer
Location
Ahmedabad, Gujarat, India
Industry
Pharmaceutical Manufacturing
Key Responsibilities
โข Prepare CTD dossiers for regulatory submissions for LATAM and ROW markets
โข Compile regulatory documentation and data from multiple departments into CTD format
โข Ensure timely compilation and submission of regulatory dossiers
โข Coordinate with cross-functional teams for document collection and preparation
โข Review and finalize dossiers before regulatory submission
โข Handle post-submission regulatory queries from authorities
โข Perform artwork review before submission
โข Prepare SmPC (Summary of Product Characteristics) and package inserts
Eligibility Criteria
Education
โข B.Pharm (Bachelor of Pharmacy) โ Required
โข M.Pharm โ Preferred but not mandatory
Experience
โข Experience in Regulatory Affairs within the pharmaceutical industry
โข Experience in Oral Solid Dosage formulations preferred
Skills Required
โข Strong understanding of drug regulatory affairs processes
โข Knowledge of CTD dossier preparation
โข Documentation and regulatory submission skills
โข Coordination and communication abilities
About the Company
Octavius Pharma Pvt. Ltd. is a pharmaceutical manufacturing organization focused on delivering quality healthcare products. The company develops and markets a wide range of formulations including tablets, capsules, dry syrups, liquid orals, ointments, nasal sprays, injectables, softgels, nutraceuticals, and herbal medicines.
Octavius Pharma also operates as a merchant exporter of bulk drugs, chemicals, finished formulations, and compressible granules while providing consulting services in formulation development, technology transfer, dossier preparation, and pharmaceutical product marketing.
The company promotes its products through a trained medical representative team and distributes them through a strong network of distributors and stockists.
How to Apply
Interested candidates can apply through the official job listing below:
Apply Here
https://www.linkedin.com/jobs/view/4385384303/