[ASP_NET_jobs] Need Regulatory Affairs Labeling Associate - Generic Labeling in NJ

Hi Partners,

 

Greetings,

 

Hope you are doing Well!!!!!!!!!!!!!!!

 

Please forward a profiles to shankar@techconsultinc.com

 

Here are the requirement details

START DATE:  11/4/13

 

INTERVIEW:   phone screen; poss. face-to-face/Skype

                    

DURATION:     6 months 

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 LOCATION:    Emerson, NJ

 

REQ. SKILLS:    Regulatory Affairs Labeling Associate – Generic Labeling

 

 

Overview:

Responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). Labeling documents include those prepared for FDA annual reports and submission labeling for Abbreviated New Drug Applications (ANDAs), amendments and supplements to ANDA's that are in compliance with regulatory requirements and within company timelines. Candidate will be required to work independently and have proficiency in FDA labeling regulations and guidance's to the level of applying them effectively to all work output.

Duties:

·         Assure all labeling and submission documents are prepared in accordance with established client standards and procedures and meet FDA requirements and guidelines

 

Expert in building compliant and accurate labeling content by being proficient in the following:

·         Obtaining needed reference materials including CMC information and Reference Listed Drug (RLD) labeling and being able to effectively develop accurate label content from these resources

·         Researching and carving out patent/s and/or exclusivity/s information based on filing strategy

·         Attend project meetings; track workload and implement labeling changes based on project responsibilities. Work with manufacturing/packaging sites concerning labeling changes and implementation, and respond to e-mail queries related to activities associated with assigned projects to ensure accurate daily workflow

·         Follows client Safety, Health, and Environmental policies and procedures

 

Skills:

·         Minimum of 2 to 3 pharmaceutical labeling experience

·         Proficiency in FDA labeling regulations and guidance's and Generic Labeling

·         Scientific background or familiarity with medical terminology preferred

·         Proficiency with electronic labeling filing and preparing SPL (Structured Product Labeling)

 

 

 

Looking forward to hearing from you at the earliest!!!

  

Regards 

 

Shankar

Professional Recruiter

33505 State Street, Suite # 200 Farmington, MI 48335

V (248)-522-6879

F (248)-579-4454

Linkedin: www.linkedin.com/in/shkrajan

Email : Shankar@techconsultinc.com

Messanger: shankarraj001@yahoo.com

Minority Certified and Woman Owned Enterprise

TCI- Technology Consultants inc

Note: It is not a solicitation attempt!!!

 

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