R E G U L A T O R Y A F F A I R S

 

Government agencies require careful documentation of procedures related to safety, production, environmental impact, personnel, etc as they regulate almost every aspect of industry operations. This requires personnel to understand the regulations and the science to make certain that all the requirements are being met and documented.

 

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Position Details

 

 

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Company Name:
Baxter Hyland Immuno

(Click Here to view all of Baxter Hyland Immuno's
positions)
Job Title:
Manager Regulatory Affairs
Date Posted:
Apr 11, 2001
Location:
Rochester, MI
Nearest Metropolitan
Area:
MI - Detroit
Country:
United States
Industry:
Biotech/Pharmaceuticals
Field:
Biochemistry
Position Level:
Manager Level
Date Position Is
Available:
Apr 11, 2001
Travel Required:
No , Unspecified
Job Duration & Work Schedule:
Length of Employment: Full Time
Shift: Day
Responsibilities:
Responsibilities: ? Ensures that products and processes meet regulatory
requirements. ? Interprets regulatory requirements both domestically and
internationally and makes recommendations as required. ? Develops
knowledge base of regulatory issues specific to the products being reviewed
by the assigned regulatory agency personnel. ? Accountable for planning,
assembling and submitting regulatory submissions. ? Manage assigned
products in conjunction with project team. Train and develops direct reports.
? Manages assigned projects to completion, including minimization of cycle
times, through direct and focused interpersonal communication. ? Facilitates
the needs of the manufacturing and engineering departments by preparing
amendments to the Division Establishment License to incorporate facility
improvements and expansions. ? Assures the regulatory submissions meet
corporate standards with respect to compliance and technical excellence. ?
Defines strategy likely to gain regulatory approval in the U.S. and
internationally.
Compensation:
Salary Range: $80,000 to $89,999
Bonus Range: Unspecified
Education:
Bachelor's degree with a scientific emphasis
Required degree: B.S.
Experience/Qualifications:
Minimum 3 years of experience required
Requirements: ? Bachelor's degree with a scientific emphasis, and 3-5 years
experience in either regulatory or clinical environments. ? Advanced degree
or equivalent experience preferred. Baxter?s Hyland Immuno Division offers
its talented professionals competitive salaries, comprehensive healthcare
benefits, pension plan, 401K plus an employee stock purchase plan. We are
an Equal Opportunity Employer M/F/D/V. For more information about Baxter,
visit our web site at: www.baxter.com

 

 

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