BENGALURU · FULLTIME
Executive/Senior Executive - Regulatory Affairs (Europe and UK Market)
Strides Pharma
Bengaluru · onsite · Posted 2d ago
Sourced from
Undisclosed1–6 yrsfulltimeBengaluru
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Section · 01
About this role
- Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for Europe and UK market for CMC and labelling aspects.
- To collate and compile new application & life cycle management CTD dossier modules from M1 to M5 for Europe and UK.
- Interpret and prepare response to the quality & administrative deficiencies as per regulatory requirement within defined timelines.
- Respond to Health Authority questions related to CMC submissions in a timely and accurate manner.
- Develop and implement regulatory CMC strategies to support new MAA and post-approval changes (PACs), variations, and life cycle activities.
- Co-ordinate with cross functional teams for document request, review, required for regulatory submission.
- Upload and publish the documents in eCTD software required for regulatory submission.
- Arranging and coordinating trainings within departments.
- Critically review documentation intended for submission for internal consistency.
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Section · 02
Skills
RA. UK marketDossierCompilationRegulatory AffairsSubmissionEctdENTCMCandaICHRACTDEurope MarketDMFNDA
Section · Company
About Strides Pharma
Strides Pharma
Pharma
3.1k+
employees
1990
36 years old
Bangalore/Bengaluru, Karnataka
India
₹11.1L PA avg
Avg at Strides Pharma
About
Strides Pharma is a global player in the pharmaceutical industry, focusing on regulated and emerging markets with a strong manufacturing and R&D presence worldwide.
Industries
Pharma
Employee ratings
10 reviews
3.9/ 5
Culture
3.9
Career growth
3.5
Work-life
4.0
Employees rate it well for
Skill Development39Overall Company39
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