Executive/Senior Executive - Regulatory Affairs (API)

Amarant Lifescience

2 - 5 years

4 - 7 Lacs

noida hyderabad

Posted:1 day ago| Platform:

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Skills Required

asmf cep regulatory affairs api drug regulatory affairs submission dossier preparation pharmaceutical mhra regulatory submissions technical data packages ctd api regulatory submission row market uk dossier ema dmf european medicines agency

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title:

Location:

Role Overview:

Regulatory Affairs Professional

Key Responsibilities:

Coordinate with cross-functional departments to arrange required technical data for
ASMF/CEP and technical package preparation
.
Review quality and manufacturing data for APIs for
regulatory adequacy
as per relevant guidelines.
Prepare
ASMF/CEP dossier sections
and technical documentation for submissions.
Review
DMFs of intermediates and APIs
as part of vendor qualification.
Assist in preparation of
amendments, deficiency responses, and post-approval variations
.
Prepare and maintain a
repository of API dossiers, regulatory commitments, and records
.
Support in drafting responses to
regulatory authority queries
based on available technical data.

Experience, Education & Skills:

Education:
Bachelors degree (or higher) in
Pharmacy, Chemistry, Biochemistry, or related scientific discipline
.
Experience:
2 - 5 years of experience in
API regulatory submissions
(ASMF/CEP) for European markets.
Proficient in
CTD/DMF/CEP
documentation and submission processes.
Familiarity with
EMA and MHRA
regulatory frameworks.
Excellent
written and verbal communication
skills.
Strong
analytical, organizational, and problem-solving
abilities.
IT proficiency
(MS Word/Excel) for document management and dossier preparation.
High degree of
professionalism and accountability
with strong work ethics.

More Jobs at Amarant Lifescience

Executive/Senior Executive - Regulatory Affairs (API)

noida, hyderabad

2.0 - 5.0 yrs

INR 4 - 7 Lacs

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