Regulatory Compliance Specialist

**Company Overview** Celogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter and manufacturer based in India, delivering products and services across multiple global markets including West Africa, East Africa, South Asia, South East Asia, the Middle East, South America, and Europe. Beyond promoting branded products in the retail sector, we actively participate in global tenders across numerous countries. Our team consists of first-generation marketing experts and distinguished technocrats in the pharmaceutical field, supported by four manufacturing facilities across India producing a diverse range of products. **Position Summary** We are seeking a detail-oriented Regulatory Affairs Specialist to prepare, submit, and maintain regulatory applications for pharmaceutical products throughout their lifecycle in designated markets. The ideal candidate will be a proactive professional with comprehensive knowledge of global regulatory guidelines, including ROW Markets and ICH requirements, with FDA and EMA knowledge being advantageous. **Key Responsibilities** **Regulatory Submissions & Documentation** • Prepare, coordinate, and review regulatory submissions, including dossiers, NODs, and tender submissions • Manage assembly and quality control of regulatory documents in CTD format • Ensure all submissions are accurate, complete, and meet regulatory timelines • Maintain and update regulatory files and databases to ensure data integrity • Prepare comprehensive Technology Transfer Documentation **Compliance and Strategy** • Monitor and interpret evolving regulatory guidelines, legislation, and industry standards • Communicate regulatory impacts to relevant internal stakeholders • Provide regulatory guidance to cross-functional teams including R&D, Clinical, Quality, and Manufacturing • Support development and implementation of regulatory strategies for product development and lifecycle management **Communication and Interaction** • Serve as primary regulatory contact for internal teams and external stakeholders • Coordinate and prepare responses to health authority inquiries and deficiencies • Represent Regulatory Affairs in internal and external audits and inspections **Qualifications** **Education** • Bachelor's degree in Pharmacy (required) • Master's degree in Regulatory Affairs (preferred) **Experience** • 3-5 years of experience in Regulatory Affairs within the pharmaceutical industry **Skills & Competencies** • Proven expertise in global regulatory requirements (ROW Markets, ICH) • Knowledge of FDA and EMA requirements advantageous • Exceptional attention to detail and strong organizational abilities • Excellent written and verbal communication skills **Employment Details** • Position Type: Full-time, Permanent • Compensation: ₹25,000 - ₹40,000 per month • Work Location: On-site