Opening for B. Pharm, M.Pharm as Regulatory Affairs Officer (2 posts) in PAR Laboratories

As a dedicated manufacturer and marketer of Hormone products, the Company concentrated on the niche areas of operations. With its beginnings in Mumbai, PAR Laboratories has been providing quality hormones and contraceptive products to various markets around the world.
In recent months, the Company has been transitioning to position itself for a substantial growth. PAR Laboratories’ acquisition by another pharma group with vast International experience opened the doors of the company to many markets. Along with it came the access to the group’s complete Research and Development facility in Navi Mumbai. This is quickening our ability to bring new hormonal products and better formulations to the market place rapidly. Over the years, PAR Laboratories has been able to identify several new product opportunities which are now in a state of development and continuous improvements.

Post: Regulatory Affairs Oficer - 2

Job Description:
• studying scientific and legal documents
• gathering, evaluating, organising, managing and collating information in a variety of formats
• ensuring compliance with Government regulations
• maintaining familiarity with company product ranges
• planning, undertaking and overseeing product trials and regulatory inspections
• keeping up-to-date with changes in regulatory legislation and guidelines
• analyzing complicated information, including trial data
• offering advice about company policies, practices and systems
• obtaining marketing permission
• outlining requirements for labeling, storage and packaging
• using a variety of specialist computer applications
• liaising and negotiating with regulatory authorities
• providing advice about regulations to manufacturers/scientists
• writing comprehensible, user-friendly, clear product information leaflets and labels
• ensuring that quality standards are met and submissions meet strict deadlines
• Preparing documentation

Additional Information:
Experience: 1-3 year
Qualification: B. Pharm, M.Pharm
Location: Gozaria, Gujarat
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 17^th Oct, 2013