Website:
ohvem.biz
Job details:
Company Description OHVEM CORPORATION is a Government of India recognized organization with multiple national and international quality certifications. The company is DUNS and Bradstreet audited and maintains ISO and GMP certifications, reflecting strong quality and process standards. OHVEM CORPORATION holds Asian CE certification, demonstrating compliance with regional product and safety requirements. The organization is registered with CDSCO and the Indian FDA, indicating active engagement in regulated sectors and a commitment to regulatory integrity. Candidates will join a company that operates within a robust, accredited, and highly regulated environment.
Role Description The Regulatory Specialist is a full-time, on-site role based in Raipur. The role involves monitoring and interpreting applicable regulatory requirements, and ensuring that company operations, documentation, and products comply with CDSCO, Indian FDA, and other relevant standards. Day-to-day tasks include preparing and reviewing regulatory submissions, maintaining and updating regulatory files, and supporting internal audits and inspections. The specialist will collaborate with cross-functional teams to provide regulatory guidance, assist in risk assessments, and contribute to the development and maintenance of compliant procedures. The position also includes drafting clear regulatory communications, tracking changes in regulations, and supporting timely responses to regulatory authorities.
MANDATORY - DOCUMENTATION CDSCO REGULATORY INFORMATION ISO AND CE MDR AUDIT
Subisdy New Factory Information and Formation
CSIDC Chhattisgarh Pharma Land
Intraocular lens and medical deices
Qualifications
- Candidates should possess skills in Regulatory Compliance and Regulatory Requirements, with experience applying these in a highly regulated environment.
- Candidates should possess Regulatory Affairs skills, including preparation of submissions, documentation management, and interaction with regulatory agencies.
- Candidates should possess strong Analytical Skills, with the ability to interpret complex regulations and assess compliance risks.
- Candidates should possess effective Communication skills, including clear written documentation and professional verbal communication with internal teams and external authorities.
- Relevant qualifications such as a degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field.
- Experience in pharmaceutical, medical devices, or other regulated industries is beneficial.
- Attention to detail, organizational skills, and the ability to work independently as well as in cross-functional teams.
- Familiarity with Indian regulatory frameworks and international standards is an advantage.
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