Officer/ Sr. Officer - Regulatory Affairs (formulations) ROW/SEA

Unichem Laboratories

2 - 5 years

3 - 6 Lacs

Mumbai

Posted:1 week ago| Platform:

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Skills Required

Row Market CTD/ ACTD Regulatory Submissions

Work Mode

Work from Office

Job Type

Full Time

Job Description

RESPONSIBILITIES

Coordination with the customer to compile the dossier as per current registration regulations in SEA & East Africa markets.
Coordination with the customer at various registration stages to obtain approval.
Analyze the molecule and determination for need of Bioequivalence or bio waiver studies.
Life cycle management of product license by filing renewals and analyzing the type of variation needed to be based on the proposed changes to DMF, formulation, packaging, or excipients.
Review and approve the artworks as per Brazil and Canada market regulations.
Interpretate deficiencies received compile and submission responses within the stipulated time frame.
Maintenance of tracker for submission and deadline for responses and coordination with stakeholders to submit responses within stipulated deadlines.

DESIRED SKILLS

Good knowledge of Registration requirements in ROW market.
Experience in submission of generic medicine dossiers to the ROW market.
Good technical knowledge, review skills and understanding of regulatory submissions
Strong knowledge of CTD/ ACTD requirements for submission of dossiers to SEA , ME & AFRICA markets.
Good analytical and problem-solving skills.
Ability to try new approaches when faced with challenges.
Should have a good analytical and learning attitude.
Proactive to submission of response to any queries.
Good communication skills.

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