Executive - Regulatory Affairs

Sun Pharma · Ankleshwar, Gujarat · Refreshed 22 days ago

About this role

Job Title Executive – Regulatory Affairs Business Unit R&D1 Regulatory Affairs Job Grade G12A Location: Panoli At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Description • To review and maintain GMP documents. • To co-ordinate QMS related activities like Change Control etc. • Approval of documents like SOP’s, STP’s etc. • To Review, follow up and compilation of data for submission of USDMF, CEP, DCP, CP, MRP for New DMF submission and DMF-Amendment / Update based on the Planning to Corporate RA, Mumbai. • To Review, follow up and compilation of data for submission of USDMF, DMF-Amendment / Update based on the Planning to Corporate RA, Gurgaon. • To Review, follow up and compilation of data for submission of Japan, China, TGA, Canadian... for New DMF submission and DMF-Amendment / Update based on the Planning to Corporate RA, Mumbai. Compilation of raw data for Registration /re-registration and queries received from authorities for ROW market, such as China, Korea, Taiwan, Indonesia, South Afric

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