Job Description
Sr. Executive / Assistant Manager - Regulatory Affairs
(ASIAN / AFRICAN / LATAM)
Roles and Responsibilities
- To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries.
- To arrange administrative documents required for dossier submission & export purpose
(Manufacturing Lic, WHO-GMP, P.P/COPPs/FSC- Procuring and legalization).
- To check & approve the artworks for regulated / semi regulated countries.
- To Co-ordinate and follow-up with manufacturer for dossier documents & samples/WS required for regulatory submission.
-Handling queries pertaining to regulatory submissions from various regulatory authorities.
- Maintain record of samples, registration certificate etc.
- To review all the dossier documents received from the manufacturer.
-Maintaining Registration tracker for assigned products country wise.
Desired Skills
-Should have good communication skill.
- Good technical knowledge, review skills, and understanding of regulatory submissions.
- Good leadership and organizational skills, with a strong focus on execution and follow-through.
Work Experience :
Work experience: 5 10 years’ experience in regulatory affairs.
Industry Type: Pharmaceutical & Life Sciences
Department: Legal & Regulatory
Education
B.Pharma in Pharmacy, M.Pharma in Pharmacy, M.SC
COMPANY NAME :- Lavina Pharmaceuticals Pvt. Ltd.
COMPANY PROFILE: - Lavina Pharmaceuticals Pvt. Ltd. Was established in the year 2004. We are the supplier and the Exporter of Pharmaceutical Formulation like Tablets, Capsules, Injectable, Creams, Infusion, and Liquids, Pharmaceuticals Intermediates, Pharmaceutical chemicals, Inorganic capsules, We are mainly involved in supplying our several range of pharmaceutical forms in East African, West Africa and Southwestern Asia, Southeast Asia,. Lavina Pharmaceuticals Pvt Ltd covers all product range like anti-infectives, anti- inflammatory and the arthritis, Cardiovascular, oncology, anti-diabetic, gastrointestinal and cough expectorant, multivitamin toxics.
Company Website:- www.lavinapharma.com
Job responses on (email id ):- admin1@lavinapharma.com
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