Piramal - Executive - Regulatory Affairs - US/EU/LATAM Markets

Industry - Pharmaceuticals

Skills - Regulatory experience in Regulated US, EU and/or LATAM markets (with focus on EU)

Job Type - Permanent

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 guidance's 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.

Contact - Afrin Patel

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