- 经验
- 2-5岁
- 薪水
- —
- 职位空缺
- 1
- 发布
- 4 周前
- 工作模式
- 在办公室
- 学历
- M.Pharm
- 合格
- Candidates with an M.Pharm degree and 2 to 5 years of relevant experience in regulatory affairs are suitable for this role.
- 恢复
- 需要申请
你的工作地点
职位描述
Role Overview
This opening is for an Executive in Regulatory Affairs within the US Group of Sun Pharma’s R&D1 Regulatory Affairs function. The position is based in Baroda/Vadodara, Gujarat, and sits at job grade G12A.
About the Organization
Sun Pharma emphasizes a culture of continuous growth, ownership, and teamwork. The company encourages employees to improve steadily, take initiative with confidence, and collaborate closely with others in a supportive environment.
What the Role Involves
- Build a strong understanding of USFDA rules, ICH guidance, regional requirements across the US, EU, and India, as well as common submission structures.
- Draft, assemble, and file regulatory submissions such as CTD/eCTD dossiers for NDAs, ANDAs, MAAs, and post-approval updates.
- Contribute to planning regulatory approaches for new products and new markets.
- Work with cross-functional stakeholders including CDMO partners, R&D, and Manufacturing teams to collect the documents and data needed for filings.
- Manage responses to questions, observations, and deficiency notices received from regulatory agencies.
- Keep regulatory records current and monitor submission schedules, milestones, and approval status.
Qualification and Experience
The role calls for an M.Pharm qualification and around 2 to 5 years of relevant experience in regulatory affairs.
Additional Information
The job description notes that it reflects the general nature and level of work for this position and is not a complete list of duties or qualifications. The employer may revise responsibilities over time or assign similar duties based on business needs and the incumbent’s background.