Piramal Enterprises Ltd. (PEL) is the flagship company of Piramal Group and has a leading position in the business verticals it is present in i.e. Healthcare
Job Title : Executive – Regulatory Affairs
Location : Mumbai
Experience : 4 – 6 Years
Job Description:
Under the guidance of the Product Team Leader, this person should be able to:
– Handle Electronic Submission of Registration dossier, variations and responses to questions in eCTD format
– File high quality submissions through DCP /MRP and National procedures for EU.. Supplements and Annual Reports for US and variation/renewals in LATAM and ROW region (as necessary).
– Respond to deficiencies from HA.
– Update himself/herself with the relevant current USFDA, EMEA and ICH guidances and requirements.
– Represent regulatory in Pharmacovigilance audits if necessary.
– Assess innovator driven product labeling updates in US, EU, LATAM and ROW and file such changes.
– Adapt and learn global regulations quickly.
Desired Candidate Profile:
– Good communication skills both spoken and written English
– Should be well versed with using excel sheets, Power Point etc
– Ready to take challenges in work
– Ready to move to different locations for work as and when required
– Will need to do coordination intra and
– Should be good at review of documents and should have good technical knowledge
– Should be able to do multi-tasking
Qualifications:
- B.Pharma – Pharmacy
