Executive / Sr. Executive / Assistant Manager - Regulatory Affairs

Lavina Pharmaceuticals

Navi Mumbai

On-site

INR 600,000 - 1,000,000

Full time

7 days ago

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Job summary

Lavina Pharmaceuticals Pvt. Ltd. is seeking an Executive to Senior Executive/Assistant Manager in Regulatory Affairs to manage dossier preparation for semi-regulated markets.

You will coordinate with manufacturers, review submissions, and ensure regulatory compliance across Africa, Asia, and LatAm regions. The role requires 3–6 years of regulatory experience with strong communication and leadership abilities.

Qualifications

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.

Responsibilities

To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in semi regulated countries.
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.

Skills

Communication

Regulatory knowledge

Leadership

Organization

Education

B.Pharma

M.Pharma

M.SC

Job description

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

Job responses on (email id ):-

admin1@lavinapharma.com

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