*Hi Partners,*
*Greetings,* *Hope you are doing Well!!!!!!!!!!!!!!!* *Please forward a profiles to **[email protected]*<[email protected]> *Here are the requirement details*** *START DATE: 11/4/13* *INTERVIEW: phone screen; poss. face-to-face/Skype* *DURATION: *6 months -- *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*<http://www.linkedin.com/in/shkrajan> *Email** : **[email protected]* <[email protected]>* * *Messanger**: [email protected]* *Minority Certified and Woman Owned Enterprise* *TCI**- Technology Consultants inc* *Note:** **It is not a solicitation attempt!!!* -- You received this message because you are subscribed to the Google Groups "SAP ABAP" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/sap-abap. For more options, visit https://groups.google.com/groups/opt_out.
