Executive / Sr. Executive / Assistant Manager - Regulatory Affairs

Executive / Sr. Executive / Assistant Manager - Regulatory Affairs
(ROW Market/Semi-Regulated Market)

• To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in semi regulated countries (Asian/African/Latam) i.e.
  African region: Nigeria, Ghana, Zimbabwe, Uganda, Madagascar, Mozambique etc.
  Asia region: Cambodia, Myanmar, Vietnam, Philippines, Congo Brazzaville, Namibia etc.
  Latam region: Guatemala, Bolivia, Costa Rica etc.
• To arrange administrative legal documents required for dossier submission along with legalisation process as applicable.
• To check & approve the registration & commercial artworks for semi regulated countries.
• To Co-ordinate and follow-up with manufacturer for dossier documents & samples/WS required for regulatory submission.
• To review all the dossier documents received from the manufacturer.
  -Handling queries pertaining to regulatory submissions from various regulatory authorities.
• Maintain record of samples, registration certificate, product renewals etc.
  -Maintaining Registration tracker for assigned products country wise.
• To collaborate with cross-functional teams & Manufacturer to support product development and compliance of the new product.
  -Handling client communications for day-to-day basis responses
• To Lead and review dossier compilation for complex submissions

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: 3 years to 6 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
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