Executive - Regulatory Affairs with USA based Pharma Company

Greetings! & very warm welcome to BEST-FIT Recruitment Riders,

highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors.

professional career opportunity

Please see the following position summary:

• Client Name: USA based Pharma Company

• Position: Executive - Regulatory Affairs (Formulations for USA market)

• Department:

  Regulatory Affairs

• Location: Ahmedabad, Gujarat

• Special Note: Immediate Joiner Required

Job Profile:

• Responsible for supporting the Regulatory Affairs department in its efforts to remain in compliance with the regulations of all intended market territories (USA Market).
• Regulatory support for assigned projects through product development and lifecycle management of products for US market.
• Review and approve labels in line with US regulatory requirements for assigned products.
• Prepare, develop, and maintain internal Regulatory informational trackers.
• Prepare technical documents required for submission of dossier as per country specific requirements.
• Respond to consumer inquiries based on approved labels and product information.
• Coordinate the receipt of raw material regulatory documents from vendors.
• Preparation of module 1 sections including labelling sections.
• Perform drug listing of assigned products for US market.
• Support publishing of ANDA submissions
• Support manufacturing site for commercialization and life cycle management of the approved products.
• Other projects and duties as assigned by Senior Management.

Desired Profile:

• B.Sc / B.Pharm / M.Sc / M.Pharm with 2 to 5 years experience in US regulatory affairs Labelling department with growing & well established pharmaceuticals.

• Immediate Joiner Required

• OTC products Experience is a Plus.
• Must have good exposure in supporting role of ANDA filling for USA market.
• Exposure in Solid Oral (Tablets & Capsules) for regulated markets (USA) would be preferred.
• Exposure to working in US Markets is Mandatory.
• Ability to compile, manage and interpret data.
• Ability to work both independently and within a team environment.
• Ability to manage several tasks simultaneously.
• Ability to co-ordinate & manage the project with external stake holder.
• Effective communicator with excellent relationship building & interpersonal skills.
• Proficiency in Microsoft Office and Adobe Acrobat.
• Strong communication skills, both verbal and written.
• Strong organizational skills.

Recruiter's Contact Details:

BEST-FIT Recruitment Riders

G-7, Amrit Complex, R.V. Desai Road,

Near Goyagate Circle, Vadodara-390001, Gujarat

Mobile: 09722042906

E-Mail: post@bfrr.in

Website: www.bestfitrecruitment.co.in