Regulatory Affairs Specialist @ PPD Pharmaceuticals B4

Job Description:
Responsibilities:

• Prepare and review regulatory submissions
  
• Liaise with internal and external clients in the tracking and status update of project plans
  
• Provide project-specific Regulatory Affairs (RA) technical expertise and co-ordination oversight for key client’s projects
  
• Liaise with PPD globally to support global projects
  
• Collaborate extensively with people throughout the company, with clients and with the regulatory authorities as appropriate
  
• Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
  
• Assist with project budgeting/ forecasting
  
• Assist in identifying and recognizing out of scope activities in a contract in a timely manner and liaise with manager to follow through on all aspects of contract modification
  
• Escalate to line manager (and other appropriate management) any issues that put project timelines, quality, etc at risk
  
• Direct other RA individuals assigned to support projects of responsibility, as appropriate
  
• Perform other duties as required
  

Qualifications
Required are:

• At least 2 years of professional experience within Regulatory
  
• Having relevant exposure in handling regulatory requirement for Europe or International market which includes Initial MA, Variations, Renewals & PSURs etc.
  
• Sound knowledge of CMC, CTD dossiers and various ICH guidelines.
  
• Additional knowledge about labelling, familiarity with globally-deployed regulatory publishing tools, processes and systems will also be an advantage.
  
• Bachelor or higher graduate degree in science-related field
  
• Very good English language skills
  
• Attention to detail and quality of documentation
  
• Effective oral and written communication skills
  
• Ability to work on own with minimal supervision
  
• Suitable experience working in the pharmaceutical/CRO industry is preferred
  

Additional Information:
Experience: Min. 2 Years
Location: Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Job Code: 112491
End Date: 30^th July, 2014

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