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Job Details

Director, Regulatory Affairs

Company: RBW Consulting
Location: Bridgewater, NJ
Reference: RA-DRA-BNJ
Closing Date: 10 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Benefits Package

Job Summary:

Our client understands that its most valuable resource is its employees. They place great value on the unique skills, talents and qualities that each of their employees brings to their company. They are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way their patients live.

Requirements:

Director, Regulatory Affairs

Bridgewater, NJ

Company Description

Our client understands that its most valuable resource is its employees. They place great value on the unique skills, talents and qualities that each of their employees brings to their company. They are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way their patients live.

They are a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.

Job Description

The Director, Regulatory Affairs has overall responsibility for providing technical regulatory input to cross-functional project teams for all project activities.

 Implements global regulatory strategies; ensuring that all regulatory requirements/commitments are met with respect to regulatory submissions (INDs, IMPDs, MAAs, NDAs) and other regional submissions.

Responsibilities:

  • Formulate & implement Regulatory plans to achieve efficient & competitive product development, working with regulatory senior management to define regulatory strategies
  • Provide regulatory direction for the coordination, and preparation of regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines
  • Provide regulatory input into cross-functional Project Teams for product development and submission activities
  • Act as regulatory lead for the review of documentation prepared by other technical functions
  • Provide regulatory review and approve of internal documentation supporting product development activities (e.g. clinical protocols, clinical study reports, statistical analysis plans, etc.)
  • Provide regulatory input into project teams in partnership with senior regulatory management as required to provide technical guidance & to assist in problem solving/issue resolution etc.
  • Assist in communications with Regulatory Agencies
  • May act as primary contact for inquiries from regulatory agencies
  • Monitor the development of new requirements or regulatory procedures
  • In partnership with Regulatory Operations, Ensure on-time submission activities related to regulatory file maintenance e.g. IND/CTA, information amendments, SAE reports, etc.)
  • Coordinate with consultants and CROs assisting with submission activities
  • Creation and oversight for maintenance of regulatory project logs, tracking the submission status of reports and other regulatory activities
     

Qualifications

  • Bachelor’s degree (scientific or clinical background desirable) required; advanced degree preferred
  • Minimum 10 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry required
  • Must have experience with creating and managing INDs/CTAs, Annual reports/DSURs, and IND/CTA information amendment submissions
  • Experience supporting marketing authorization applications (e.g. NDA, NDS and MAA) a plus. Must have experience with electronic format (eCTD) submissions
  • Experience in submission writing and review experience essential
  • Experience with combination (drug/device) products a plus
  • Experience of direct interaction with Regulatory Agencies also a plus
  • Strong interpersonal and written/verbal communication skills essential
  • Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter
  • Excellent computer skills; MS Word and Adobe Acrobat are required. Experience with preparing submission-ready PDFs and use of Microsoft Excel highly desired
  • High ethical standards for compliance to regulations and procedures is essential
  • Initiative, combined with a high energy level is critical to success
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at (646) 586 9087 today!
 

Apply for this job: Director, Regulatory Affairs

Contact Information:

Address:  US Team
Origin Two 106 High Street, Crawley
RH10 1BF
England
Tel:  (646) 586 9087
Website:  Visit Our Web Site

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