DGM - Regulatory - Device
Sun Pharma is seeking a DGM for Regulatory Affairs focused on medical devices and combination products. The role involves leading regulatory strategies, managing global submissions like 510(k) and PMA, and ensuring compliance across the US, Canada, and EU. The successful candidate will guide cross-functional teams, handle agency engagements, and support product lifecycle management. This position requires 15+ years of experience and deep expertise in international device regulations and organizational leadership.
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Experience
15+ years
Function
Engineering
Work mode
Hybrid, India
Company
Tier 2
What you will work on
Sun Pharma is seeking a DGM for Regulatory Affairs focused on medical devices and combination products. The role involves leading regulatory strategies, managing global submissions like 510(k) and PMA, and ensuring compliance across the US, Canada, and EU. The successful candidate will guide cross-functional teams, handle agency engagements, and support product lifecycle management. This position requires 15+ years of experience and deep expertise in international device regulations and organizational leadership.
TAL's take
Senior leadership role at a prominent pharmaceutical firm with clear domain focus and significant regulatory responsibility.
The JD is highly specific regarding regulatory pathways, documentation types, and required experience in medical device compliance.
Salaries at Sun Pharma
10.2 LPA average
Based on 4 Grapevine salary entries for Sun Pharma.
Sales
2 - 4 years
5 LPA average
Range: 5 - 5 LPA
Other roles
4 - 6 years
10 LPA average
Range: 10 - 10 LPA
Accounting
6 - 8 years
20 LPA average
Range: 20 - 20 LPA
Must haves
- 15+ years of progressive medical device regulatory experience
- Hands-on experience with FDA submissions (510(k), PMA, IDE)
- Experience with EU MDR and CE marking
- Experience with Health Canada device licensing
- Experience with combination products (drug/device)
- Strong staff and organizational development experience
Tools and skills
About the company
Major pharmaceutical company, but not classified as a Tier 1 global tech firm or Indian consumer tech unicorn.
Posts mentioning Sun Pharma
Need a place in Mumbai
Anyone open to rent their place or shared apartment for like short term basis? I am asking for sun-letting for like 15-20 days We can figure out the rent. Zostel seems expensive for longer stay and then you have to figure out food as well
(Game time) Let's play it ⏯️▶️⏯️
So, you have to comment on your life scenario and song . Scenario may be related to job, life, love, family anything under the sun. Song should be apt I'll go 1st... Scenario - Thinking of taking a sabbatical after 8y of corporate mazdoori. Song dedicated to scenario - Ek din mit Jaega mati k mol https://youtu.be/Zuiup_NOYh8?si=3wFWaSk9LnOxx-p5 Let's Play...
Oracle may not like this 🤣
But his parents would be proud of their Sun 😄