Job description
About Us:
Sushen Medicamentos is a leading pharmaceutical company committed to delivering high-quality, affordable medicines globally. With EU GMP-certified manufacturing facilities, we adhere to the highest standards of quality and compliance. Our dedication to excellence drives our mission to improve health outcomes worldwide.
Position Overview:
We are seeking a dynamic and detail-oriented Regulatory Affairs Executive with 2–3 years of experience in the pharmaceutical industry. The ideal candidate will have a strong understanding of regulatory requirements, particularly within EU, ROW markets etc. And will play a pivotal role in ensuring compliance and facilitating product registrations.
Key Responsibilities:
- Regulatory Submissions:
- Prepare, compile, and submit regulatory dossiers (e.g., CTD/eCTD) for product registrations, renewals, and variations in compliance with EU and other international regulatory requirements.
- Liaise with regulatory authorities to address queries and ensure timely approvals.
- Ensure dossiers are accurately formatted, hyperlinked, and submitted via appropriate electronic submission platforms such as eCTD Gateway (US FDA), CESP (EMA), or country-specific portals.
- Compliance and Documentation:
- Ensure that all products comply with current regulations and guidelines (e.g., EMA, ICH, WHO).
- Maintain up-to-date regulatory files and databases, ensuring accuracy and completeness.
- Cross-Functional Collaboration:
- Work closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to gather necessary documentation and information for regulatory submissions.
- Provide regulatory guidance during product development and lifecycle management.
- Regulatory Intelligence:
- Monitor and analyze changes in regulatory requirements and communicate relevant updates to internal stakeholders.
- Participate in the development and implementation of regulatory strategies to ensure compliance and competitive advantage.
- Audit and Inspection Support:
- Prepare for and participate in regulatory inspections and audits, including those related to EU GMP compliance.
- Implement corrective and preventive actions (CAPAs) as necessary.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- 2–3 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of EU regulatory requirements and GMP standards.
- Experience with electronic submission platforms and regulatory databases.
- Strong organizational and project management skills.
- Excellent written and verbal communication skills.
Preferred Qualifications:
- Experience with EU GMP-certified manufacturing processes.
- Familiarity with global regulatory frameworks beyond the EU.
Pay: ₹242,072.46 - ₹1,178,893.80 per year
Experience:
- Regulatory: 1 year (Required)
- Pharmaceutical: 1 year (Required)
Work Location: In person
