Regulatory Specialist
Location: Braintree Massachusetts
Description: Biomet is looking of Regulatory Specialist right now, this position will be placed in Massachusetts. For complete informations about this position opportunity please read the description below. Position is responsible for ensuring that global regulatory submissions are appropriately developed for approval. These Regulatory submissions can include, but are not limited to New Drug Application! s (NDAs), Investigational New Drugs (INDs) and Supplements. Ensures regulatory interface throughout the product realization process and during the entire product life cycle including post-market surveillance.
Essential Duties:
Sit on design/project review teams and provide interactive feedback and assist in the development of supporting documentation.
Develop Regulatory strategy for projects.
Assist in the development and implementation of the post-market surveillance.
Develop documents to submit to FDA
Annual Reports
Periodic Adverse Drug Experience (ADE) Reports
Prior Approval Supplements (PAS) Submissions
Change Being Effected (CBE) Submissions
Changes Being Effected in 30 days (CBE-30) Submissions
Drug Mater File Updates and Revisions
Other submissions to address miscellaneous inquiries as needed
Develop documents for International Regulators such as Te! chnical Files and updates.
Develop internal documenta! tion when formal FDA submissions are not required (Letters or memo-to-file).
Review and approve marketing literature, including labels, instructions for use, and other items for internal and external dissemination.
Review and approve Change Requests (CRs).
Assist in the development and updating of internal standard operating procedures.
Coordinate with International regulatory on submission timelines and the dissemination of information.
Liaise with Corporate Regulatory Compliance departments to ensure appropriate reporting of adverse events for Class IIa and IIb products.
Develop progress reports and other misc. reports as needed.
Participate in special projects as needed.
Limited travel required (up 5%)
Performs related duties as required.
Job Specifications: Requires the ability to work with a variety of levels both within and outside the organization. Working knowledge of FD! A regulations and how to interpret and monitor them.
Skills And Abilities:
Knowledge of domestic/international drug and medical device regulations
Strong attention to detail
Strong computer skills, including word
processing, spreadsheet and data programs
Excellent oral and written communication skills
Knowledge and skills identified are typically acquired by completing Bachelor’s or higher degree in science. Two to four years experience in pharmaceutical regulatory affairs is desired.
Working Climate: Tasks involve the ability to exert light physical effort in sedentary to light work, but may involve some lifting, carrying, pushing or pulling of objects and materials of weight up to 25 pounds.
- .
If you were eligible to this position, please email us your resume, with salary requirements and a resume to Biomet.
If you interested on this position just click on the Apply button, you will be redirected to the official website
This position starts available on: Thu, 08 Aug 2013 19:09:25 GMT
0 comments:
Post a Comment