Executive / Sr. Executive- Regulatory Affairs (Branded)
0 - 5 Years of Experience
Not disclosed 
Full TimeSun Pharmaceutical Industries Limited
Mumbai, Maharashtra, India
Posted on 14-04-2023
701 Views
1 Vacancy
Description
- This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed biologic products across globe. Regulatory activities focus on filing activities/query responses/post approval changes as suggested across globe.
- Incumbent will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality.
- Understanding country specific requirements, particularly for EM, and sharing additional data generation/gap assessments with CFT
- Closely work with consultants, partners and local regulatory colleagues to understand regional requirements.
- Preparation of Agency consultation packages, briefing book and required presentations and engage with Agency for consultations
- Provide CMC support for other branded projects as needed.
- Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.
- Responsible for preparation of IND and IMPD documents
- Providing consistent support to commercial and clinical teams.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Preferred Education
MPharm Industrial PharmacyMSc (Master of Science)
Key Skills
Effective Communication SkillsProblem Solving SkillsDecision-MakingTeam ManagementTeam working SkillsPositive Attitude
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