Walk-ins For Regulatory Affairs- ROW - Formulations

Shilpa Medicare

4 - 9 years

5 - 12 Lacs

Hyderabad/Secunderabad

Posted:7 hours ago| Platform:

Apply

Skills Required

Regulatory Affairs eCTD Stability BMR PV Europe MFC GMP CoPP Cis Dossiers MENA RA EU CTD Asia Formulation Latam Artworks RoW DMF US PDR Emerging Markets

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities

Should Have Formulation Experience.

Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions

Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region
Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format.
Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities.
Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration.
Responding to queries with in the time lines received from client/agency.
Preparation of check list as per country specific requirements region.
Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region.
Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration.
Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base.
Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency.
Filing of variations if any and registration renewals.
Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments.
Maintaining the product status (Registered and Under registration) in excel sheet.

Desired Candidate Profile

Should Have Regulatory Affairs Relevant Formulation Experience

Perks and Benefits

More Jobs at Shilpa Medicare

Operator / Sr. Operator / Officer / Sr. Officer / Executive / Sr. Exec

Jadcherla

2.0 - 7.0 yrs

INR 2 - 6 Lacs

Senior Executive/ Assistant Manager - Purchase (Formulation)

Hyderabad

4.0 - 8.0 yrs

INR 4 - 8 Lacs

Dy Manager/Manager- Regulatory Affairs- ROW - Formulations

Hyderabad/Secunderabad

5.0 - 10.0 yrs

INR 7 - 14 Lacs

Preclinical scientist

Hyderabad

6.0 - 10.0 yrs

INR 6 - 13 Lacs

Regulatory Affairs - US/EU/CA -Executive/Sr Executive

Hyderabad

2.0 - 7.0 yrs

INR 2 - 7 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.