Job Summary:
We are seeking a highly skilled Regulatory Affairs – Assistant Manager (Europe Market) to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.
Essential Duties and Responsibilities:
Technical Expertise
- Proven experience in preparing CEPs/ASMFs from scratch.
- Experience in submitting and maintaining ASMFs/DMFs and CEPs (initial submissions and variations) to the EDQM and/or European National Competent Authorities.
Regulatory Compliance
- Ensure company products comply with relevant regulatory requirements and local regulations.
Software Knowledge
- Familiarity with electronic submission systems and validation software such as Pharmaready and Lorenz.
Document Preparation
- Proven ability to independently prepare Modules I, II, and III for APIs and Excipients.
Login/Account Creation
- Knowledge of creating company logins/accounts on various country regulatory portals.
Regulatory Strategy
- Develop and implement regulatory strategies to support product development and commercialization.
Regulatory Intelligence
- Stay up to date with changing regulatory requirements and provide guidance to internal stakeholders.
Audits and Inspections
- Coordinate and manage regulatory audits and inspections.
Regulatory Agency Interactions
- Communicate with regulatory agencies such as the European Medicines Agency, European Directorate for the Quality of Medicines & HealthCare, and U.S. Food and Drug Administration to address questions and concerns.
Regulatory Documentation
- Maintain and manage regulatory documents, including submissions, approvals, and correspondence.
Training and Guidance
- Provide regulatory training and guidance to internal stakeholders.
Compliance Monitoring
- Monitor company activities to ensure compliance with regulatory requirements.
Additional Advantage
- Experience in preparing and submitting DMFs, Master Files, and regulatory submissions for regions including:
- United Kingdom
- Australia
- Brazil
- GCC
- Jordan
- Switzerland
- Ukraine
- Tunisia
- Singapore
- Mexico
Skills:
- Strong knowledge of regulatory submissions and dossier preparation.
- Strong knowledge of regulatory research and compliance requirements.
- Familiarity with chemical industry-specific regulations and guidelines.
Pay: ₹800,000.00 - ₹1,200,000.00 per year
Benefits:
- Health insurance
- Life insurance
- Provident Fund
Work Location: In person
