Regulatory Affairs Officer

5 months ago

Science City Ahmedabad Gujarat, India Vetenza India Pvt Ltd. Full time

Hiring for a **REGULATORY AFFAIRS OFFICER ** for our **Ahmedabad **location.
Freshers with good knowledge should apply

**Key Responsibilities**:

- Assist in the preparation, compilation, and submission of regulatory documents, such as drug master files (DMFs), technical dossiers, and regulatory filings, to health authorities and regulatory agencies.
- Maintain and update regulatory documentation and databases, ensuring accuracy, completeness, and compliance with regulatory requirements and internal standards.
- Coordinate regulatory activities with internal stakeholders, including R&D, manufacturing, quality assurance, and marketing teams, to ensure alignment with regulatory requirements and project timelines.
- Review and assess manufacturing and quality control documentation, including batch records, specifications, and validation reports, to ensure compliance with regulatory standards and guidelines.
- Support regulatory assessments and audits by internal and external parties, including regulatory agencies and customers, by providing documentation and information as requested.
- Monitor changes in regulatory requirements and guidelines applicable to finished pharmaceutical manufacturing and communicate updates to relevant stakeholders to ensure ongoing compliance.
- Assist in the preparation of responses to regulatory inquiries, deficiency letters, and requests for additional information from regulatory agencies, ensuring timely and accurate responses.
- Participate in regulatory training and education programs for employees to enhance awareness and understanding of regulatory requirements and best practices.
- Contribute to continuous improvement initiatives within the Regulatory Affairs department, including process optimization, standardization, and implementation of best practices.
- Perform other duties and responsibilities as assigned by the Regulatory Affairs Manager or other senior management personnel to support departmental objectives and organizational goals.

**Requirements**:

- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or a related field. Advanced degree (e.g., M.Pharm, MSc) preferred.
- Minimum of 1-3 years of experience in regulatory affairs roles within the pharmaceutical industry, with exposure to finished pharmaceutical manufacturing processes.
- Knowledge of regulatory requirements and guidelines applicable to finished pharmaceutical products, including but not limited to ICH guidelines, GMP regulations, and pharmacopoeial standards.
- Familiarity with regulatory submission processes, documentation requirements, and electronic submission systems (e.g., eCTD).
- Strong attention to detail and organizational skills, with the ability to manage multiple tasks and priorities effectively in a fast-paced environment.
- Excellent communication and interpersonal skills, with the ability to collaborate cross-functionally and interact with internal and external stakeholders.
- Proactive and self-motivated attitude, with a commitment to continuous learning and professional development in the field of regulatory affairs.

**Salary**: ₹12,000.00 - ₹25,000.00 per month

Schedule:

- Day shift

Ability to commute/relocate:

- Science City, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

**Language**:

- English (required)

Work Location: In person

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