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Job Details

Senior Manager, Regulatory Affairs

Company: Chiltern
Location: Home or office based in the US
Reference: 6751
Closing Date: 10 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Chiltern is hiring. The Senior Manager Regulatory Affairs is responsible for the preparation of clinical trial applications and the management of regulatory liaison activities with competent authorities. Ensure Chiltern’s data integrity standards, compliance with all local and regional regulatory requirements. Oversee the development, implementation, communication, and consistent application of relevant regulations, regulatory guidance and precedents.

Requirements:

Job Background

  • Preparation of regulatory submissions to competent authorities
  • Respond to questions/objections from competent authorities
  • Actively support the development of the department, consistent with the company’s corporate direction and meeting the needs of current and future clients
  • Preparation of Drug Development Plans
  • Ensure that Regulatory activities are supported by robust procedures (SOPs, WPDs etc.), and up-to-date electronic systems sufficient for the scope of activities provided
  • Liaison with competent authorities
  • Maintain communication with sponsors to assure acceptable project fulfillment
  • Ensure the Regulatory department has and maintains up-to-date knowledge to meet all country and region-specific regulatory requirements.
  • Perform other duties as required by the Department 

 

Skills:

  • Bachelor’s degree in Life Sciences or related discipline.  Post-graduate degree in Life Sciences preferred
  • Minimum 2-4+ years of experience in Regulatory Affairs Management
  • Ability to maintain confidentiality of data and information during interactions with staff at all levels
  • Experience in Regulatory Affairs studies across phases and therapeutic areas
  • Extensive knowledge of global Regulatory Affairs for clinical trials and licensed products.
  • Good understanding of budget and  financial planning and management
  • Demonstrated ability to conduct Regulatory Affairs activities effectively, efficiently and with the minimum of supervision
  • Thorough understanding of the principles of ICH GCP and regulatory requirements


Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

depends upon experience

Position Type

Permanent
Full Time

Contact

Email Michelle Gerardi - Michelle.Gerardi@Chiltern.com
+1 774 272 5506

Apply for this job: Senior Manager, Regulatory Affairs

Contact Information:

Address:  Illinois, USA
1425 Tri-State Parkway, Suite 110 Gurnee, USA
IL 60031
USA
Website:  Visit Our Web Site

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