F&D Executive
verified
3 - 5 Years of Experience
3.50L - 4.50L Per Annum
Full Time
3 - 5 Years of Experience3.50L - 4.50L Per AnnumFull TimeRhydburg Pharmaceutical Limited
Dehradun, Uttarakhand, India
Posted on 02-04-2024
271 Views
1 Vacancy
Description
- Conduct research and stay updated on regulations and guidelines issued by regulatory authorities such as the FDA, EMA, and other relevant agencies.
- Assist in the preparation and submission of regulatory documents for new drug applications (NDAs), abbreviated new drug applications (ANDAs), investigational new drug applications (INDs), and other regulatory submissions.
- Review and evaluate product labelling, packaging, and promotional materials to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams including R&D, quality assurance, and legal departments to ensure compliance with food and drug regulations throughout the product lifecycle.
- Participate in regulatory inspections and audits, and assist in responding to inquiries and findings from regulatory authorities.
- Assist in the development and implementation of quality management systems (QMS) to ensure compliance with current Good Manufacturing Practices (cGMP) and other regulatory standards.
- Provide regulatory guidance and support to internal stakeholders on matters related to product development, manufacturing, and commercialization.
- Conduct internal audits and assessments to identify areas for improvement and ensure adherence to regulatory requirements.
Category
R&D / F&D / ADL / Pharma Research
Preferred Education
BPharm (Bachelor Of Pharmacy)
Key Skills
Analytical SkillsRegulatory ComplianceQuality Management SystemsRisk ManagementInspection Preparation
About Organization
tablets , capsules ,Liquid & ointment
Contact Info
Address:
C2&3, SIEL, SARA Industrial RD, Dehradun, Uttarakhand 248197