Novo Medi Sciences (Novo Group) is a leading pharmaceutical company dedicated to innovation and excellence, with having more than 75 years of presence in the healthcare sector. We are committed to delivering cutting-edge solutions and improving lives through pioneering the introduction of life saving critical care molecules & vaccines in India. Role Overview: We are seeking a dynamic and experienced professional for the position of Regulatory Affairs – Senior Executive Qualification: B Pharm / M Pharm. Location: - Dadar East, Mumbai, Maharashtra. Experience: - Minimum 5 years of thorough experience in below given JD. Salary up to 12 LPA. Reporting structure: Reporting – Manager Regulatory Affairs & MD. Job Description: • Expertise of compiling & reviewing ACTD, CTD dossiers of Finished formulation for non-regulated & Semi regulated markets.. • Reply queries raised by MOH of relevant Territory on dossiers submitted. • Checking art works and samples of the products and ensure compliance. • Interaction and coordinating with international agent for dossier submission and registration status • Maintain Product's Lifecyle and all records of technical documentations, registrations. • File variations and renewals of Products. Show more Show less

Key Responsibilities: Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa. Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance. MOH Query Response: Address and respond to any Ministry of Health (MOH) queries for dossiers submitted in the relevant territories. Compliance: Review product artworks and samples to ensure compliance with regulatory requirements. International Coordination: Liaise with international agents for dossier submission, follow-up, and product registration. Documentation: Maintain comprehensive records of technical documentation, product registrations, and related expenses. Team Management: Lead and manage the regulatory affairs team, ensuring deadlines and regulatory goals are met. Requirements: Proven expertise in the regulatory field of pharmaceutical finished formulations for CIS, LATAM, and African markets. Experience in compiling and reviewing ACTD and CTD dossiers. Proficiency in handling MOH queries and ensuring timely responses. Strong attention to detail in checking product artwork and samples for regulatory compliance. Ability to effectively coordinate with international agents and manage the dossier submission and registration processes. Solid organizational skills for maintaining technical documentation and tracking expenses. Team management experience, with the ability to lead, mentor, and develop a high-performing team. Preferred Qualifications: Bachelor's or Master's degree in Pharmacy, Regulatory Affairs, or a related field. Minimum 10+ years of experience in regulatory affairs in the pharmaceutical industry. Strong understanding of international regulatory requirements for CIS, LATAM, and Africa regions. Excellent communication and coordination skills with cross-functional teams and international agents. Other Benefit Working Days – 6 days ( 2nd and 3rd Sat off ) Timing – 10 am to 7 pm Paid leaves – 21 Public Holiday- 12 Show more Show less

Novo Medi Sciences (Novo Group) is a leading pharmaceutical company dedicated to innovation and excellence, with having more than 75 years of presence in the healthcare sector. We are committed to delivering cutting-edge solutions and improving lives through pioneering the introduction of life saving critical care molecules & vaccines in India. Role Overview: We are seeking a dynamic and experienced professional for the position of Regulatory Affairs – Manager. Qualification: B Pharm / M Pharm. Location:- Dadar East, Mumbai, Maharashtra. Experience: - Minimum 10 years of thorough experience in below given JD. Reporting structure: Reporting – MD. Job Description: Expertise of compiling & reviewing ACTD, CTD dossiers of Finished formulation for non-regulated & Semi regulated markets.. Reply queries raised by MOH of relevant Territory on dossiers submitted. Checking art works and samples of the products and ensure compliance. Interaction and coordinating with international agent for dossier submission and registration status Maintain Product's Lifecyle and all records of technical documentations, registrations. File variations and renewals of Products. Team Handling experience