Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Associate Director ensuring quality compliance in clinical and safety processes for a global pharmaceutical. Involved in regulatory intelligence, change control, and continuous improvement initiatives.
Responsibilities
- Ensure compliance to Regulatory Intelligence Procedures
- Execute the regulatory intelligence process in partnership with compliance teams
- Implement change control for new and revised regulations
- Oversee reviews and closure of routine and complex change controls
- Provide data insights to emerging regulations and compliance metrics
- Participate in enterprise-wide projects and initiatives
- Support implementation of new and revised processes across CPMQ
- Contribute to the Clinical and Safety Quality Compliance strategy as part of the Leadership Team
Requirements
- BSc in a scientific or allied health/medical field (or equivalent degree)
- Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry
- At least 3 years of experience in GCP Quality/Compliance
- Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH)
- Successful development and implementation of a clinical or pharmacovigilance audit program
- Experience hosting/leading regulatory inspections and remediation activities on a global level
- Skilled in managing global, cross-functional projects
- Successful management of business transformation/change management initiatives
- Excellent communication skills and active listening skills
- Outstanding problem-solving abilities
- Fluency in written and spoken English, additional language skills a plus
Benefits
- Medical, dental, vision insurance
- 401(k) plan with company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Up to 80 hours of sick time per calendar year
- Up to 120 hours of paid vacation for new hires
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