Regulatory Specialist 2

Industry

Pharmaceuticals

Advert ID

FOX_BBBH34000

Location

Lake Zurich

Job Type

Contract

Hours

Full-Time

Salary Range

Up to USD0.00 per year

No. of Openings

1

Branch Information

Milwaukee Engineering - (USA) 100 Manpower Place WI Milwaukee , WI 53212

ContactNumber

414-231-1150

Job Description

Location: Lake Zurich, IL (60047)



Hours: 8:00am - 5:00pm, M-F



Contract Length: 9 months with possibility for extension







Summary



The main function of a regulatory specialist is to implement policies and coordinate community affairs strategies. A typical regulatory specialist will develop and maintain supportive relationships with regulatory bodies.







Responsibilities



* Compile and maintain regulatory documentation databases or systems.

* Coordinate efforts associated with the preparation of regulatory documents or submissions.

* Analyze product complaints and make recommendations regarding their reportability.

* Develop or conduct employee regulatory training.

* Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

* Escort government inspectors during inspections and provide post-inspection follow-up information as requested.

* Coordinate, prepare, or review regulatory submissions for domestic or international projects.

* Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.







Skills



* Verbal and written communication skills, attention to detail, customer service and interpersonal skills.

* Ability to work independently and manage one's time.

* Knowledge of legal policies and procedures related to hiring practices (i.e., equal employment opportunity and affirmative action).

* Knowledge of benefit and pay-scale systems.

* Previous experience with computer applications, such as Microsoft Word and Excel.







Education/Experience



* Bachelor's degree in related field desired

* 2 - 4 years of experience







Additional Information



This person will need to have Regulatory Affairs experience in filing Abbreviated New Drug Applications (ANDA), supplements and annual reports for approved products.