SANVIN Group, a reputable name in the pharmaceutical industry, specializes in the manufacturing and export of Active Pharmaceutical Ingredients (APIs). Renowned for its innovative drug development capabilities, the company focuses on maintaining high standards of quality and regulatory compliance. With its presence in Thane, Ambarnath, and Dombivli, SANVIN Group is committed to empowering healthcare worldwide through excellence in pharmaceutical solutions.
Key Responsibilities in the Role
As a Regulatory Executive (API) at SANVIN Group, your primary duties will include:
- Drug Master File (DMF) Preparation:
- Developing DMF submissions in e-CTD/ACTD/NeeS formats.
- Submitting ASMFs via various procedures, including Decentralized, National, and Centralized, to European health authorities.
- Deficiency Responses:
- Addressing deficiencies from health authorities such as EDQM, TGA, HSA, SWISSMEDIC, and NPRA.
- Responding to customer queries regarding ASMFs.
- Life Cycle Management:
- Preparing annual reports, notifications, and renewals for submitted DMF/ASMFs.
- Conducting impact analyses of regulatory changes and filing self-amendments and variations.
- Document Review:
- Reviewing technical documents like analytical method validations, process validation reports, batch production records, drug development reports, and stability data.
- Regulatory Compliance:
- Ensuring adherence to country-specific regulatory requirements.
- Preparing facility manufacturing accreditation for Japan and reviewing technical data packs for vendor approval.
- Cross-Department Coordination:
- Acting as a liaison between various departments to gather necessary documentation for submissions.
Required Qualifications
- Educational Background: A degree in Pharmacy, Chemistry, or a related field. Advanced certifications in regulatory affairs will be advantageous.
- Experience: 4–5 years of experience in regulatory documentation and compliance for APIs.
- Industry Knowledge: In-depth understanding of regulatory procedures in Europe, Japan, and other international markets.
Essential Skills
- Technical Expertise:
- Proficient in e-CTD/ACTD/NeeS submissions.
- Knowledge of regulatory frameworks for health authorities like EDQM, TGA, HSA, and others.
- Communication:
- Strong written and verbal skills to address deficiencies and collaborate with internal and external stakeholders.
- Analytical Ability:
- Detail-oriented with the ability to analyze regulatory changes and their implications on product registration.
- Teamwork:
- Capable of coordinating with multidisciplinary teams to achieve regulatory compliance.