Regulatory Affairs - Manager/Senior Executive

Company Description

Olive PharmaScience Ltd has been a leader in global healthcare innovation for over five decades, providing high-quality pharmaceutical solutions tailored to diverse needs. As an integrated pharmaceutical company based in India, we specialize in developing and manufacturing customized pharmaceuticals, OTC products, and dietary supplements, with expertise in soft gelatine dosage forms. With three state-of-the-art manufacturing facilities meeting cGMP standards, we serve global clients with precision and reliability. Our commitment to innovation and excellence enables us to enhance the bioavailability and therapeutic effectiveness of formulations while setting new standards in patient care. Olive PharmaScience Ltd combines cutting-edge technology with tradition to redefine the science of oral dosage forms.

Role Description

This is a full-time on-site role located in Daman for a Regulatory Affairs - Manager (8-10 Years of Experience)/Senior Executive(5-7 Years of Experience).

The selected candidate will handle regulatory verification/submissions, coordinate with regulatory bodies, prepare and review regulatory documents, ensure compliance with applicable regulations, and support product registration and approval processes. The role also involves cross-functional collaboration to gather necessary data, maintaining product approval timelines, keeping up-to-date with regulatory changes, and ensuring alignment with international regulatory guidelines.

Qualifications

• Strong knowledge of regulatory guidelines, compliance requirements for pharmaceuticals, and experience with the preparation of regulatory submissions
• Proficiency in document review, dossier preparation, and ensuring accuracy and completeness of technical files
• Familiarity with international regulatory standards like US FDA, EMA, and WHO-GMP requirements and regulated and ROW markets
• Strong communication, organizational, and project management skills for maintaining compliance and timelines
• Ability to work collaboratively in cross-functional teams
• Educational qualifications in Pharmacy, Science, or a related discipline
• Prior experience in a regulatory affairs role, particularly in the pharmaceutical industry, is preferred
• Attention to detail, problem-solving skills, and the ability to stay updated with evolving regulatory frameworks

If you are open to exploring a new opportunity, kindly write to us on regulatory2.ho@olivepharmascience.com