Regulatory Affairs Pharmacist at MSN Laboratories

MSN Laboratories is one of the fastest-growing, research-based and fully integrated pharmaceutical companies based out of Hyderabad, India. It was founded in the year 2003 with a mission to make high-quality medicines affordable and accessible to the world. The organization presently has 22 state-of-the-art manufacturing facilities (15 API and 7 Finished Dosage Facilities) established across India and USA.

We are recruiting to fill the position below:

Job Title: Regulatory Affairs Pharmacist

Location: Lagos

Responsibilities

• Coordinating & submitting new registration, renewal and variation dossiers
• Fastracking & Ensuring the timely obtaining of registrations
• Assist In-House Regulatory team in addressing the queries raised by Regulatory Agencies.
• Coordinating & preparing of Hospital formulary dossiers
• Submission of tender documents, samples and the final tenders to relevant organization
• Review regulatory guidelines and updating Head office on the new requirement changes
• Coordinate GMP application and follow up for site inspections and issuance of cGMP certificates
• Assist in developing labeling content compliant with regional requirements, ensuring accuracy and consistency & compliance across multiple markets
• Review marketing materials for accuracy and compliance with applicable regulations, minimizing legal exposure for the company
• Establishing strong relationships with key stakeholders at regulatory agencies &
• fostering open communication channels for prompt issue resolution
• Maintaining contacts and sharing relevant information with relevant disciplines, internally and externally, nationally, and internationally
• Report ADRs and other pharmacovigilance reporting tools from principals to the regulatory bodies

Qualifications

• Must be a Resident & Registered Pharmacist in Nigeria
• Proven track record of successful regulatory filings & Registrations
• Minimum of 5 years of experience in Regulatory filings
• Prior experience of IRIMS (Regulatory Data Base) handling
• Expertise in regulatory norms of the Ghana & Nigeria
• Prior experience of working with NAFDAC & Ghana-FDA
• Thorough knowledge of eCTD Dossier.

Application Closing Date
Not Specified.

How to Apply
Interested and qualified candidates should:
Click here to apply online