Regulatory Affairs Executive Hiring at Bangalore SurgeWay Biosciences

Regulatory Affairs Executive Job Vacancies

SurgeWay Biosciences, located in Bangalore, is seeking skilled professionals to join their team as Regulatory Affairs Executives. If you have an M.Pharm qualification and experience in dossier preparation for ROW markets, this role offers the perfect opportunity to elevate your professional journey.

SurgeWay Biosciences Recruitment Notification

SurgeWay Biosciences, a prominent name in the pharmaceutical industry, is renowned for its commitment to innovation and excellence. The company is looking for experienced individuals to strengthen its Regulatory Affairs team.

Position Details

• Job Title: Regulatory Affairs Executive
• Location: Bengaluru, Karnataka, India
• Experience Required: 2-3 years in Regulatory Affairs (ROW Markets)
• Qualification: M.Pharm (preferred candidates with immediate availability or a 15-day notice period)

Roles and Responsibilities

As a Regulatory Affairs Executive, you will play a pivotal role in ensuring that SurgeWay Biosciences meets the highest regulatory standards in the ROW markets.

Roles & Responsibilities:

• To prepare and compile a registration dossier as per the CTD / ACTD / Country specific guidelines – specifically for ROW markets (Myanmar, Cambodia, Philippines, Nigeria, Zambia, Ethiopia, Kenya)
• Must be aware of the contents of a Dossier, and should be knowledgeable about all the documents attached in dossiers
• To prepare, review /check artwork, pack insert, SmPC, etc.
• To verify all technical documents and information received from various departments at the manufacturing site.
• To verify specification of excipients, active, finished product, and packaging material and all required documents.
• Must be aware of Biosimilars/Drug products submission procedure for ROW countries
• Must be aware of the ICH guidelines and the updates on the same
• To reply to any queries raised by respective regulatory authorities, in a timely manner.
• Maintains the highest level of submission standards.

Candidate Profile

SurgeWay Biosciences seeks dynamic individuals with the following qualifications and skills:

Educational Qualification:

• M.Pharm degree with specialized knowledge in Regulatory Affairs.

Professional Experience:

• 2-3 years of experience in dossier preparation and submission for ROW markets (South East Asia and East Africa).

How to Apply?

Interested candidates can apply for the Regulatory Affairs Executive role at SurgeWay Biosciences through the following link:
Apply Now

Tagged as: Global Pharma Jobs, Pharmaceutical Careers