Login


New to IMS? Register Now

Forgot Your Password?

Director Global Regulatory Affairs

Cambridge, MA and Bridgewater NJ
Job Order: GD-725

Job Description:

  • Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for rare disease indications which adhere to US regulatory and company guidelines.
  • Represent the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy documents.
  • Lead the strategic development of briefing materials and prepare teams for US FDA meetings.
  • Participate in the development of and assess the appropriateness of submission documentation to support successful INDs/NDAs/BLAs.
  • Represent the company at US FDA for assigned projects.
  • Work with the NA labeling strategist and the Global Regulatory Team to develop US prescribing information.
  • Work with and participate on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and products.
  • Consult with senior management to develop and communicate regulatory strategies and advice for products and programs.
  • Participate in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations.
  • Supervise, and/or coach mentor, junior staff supporting regulatory team.
  • Ensure compliance with all regulatory and internal company policies

 

Job Requirements:

  • At least 10 years’ regulatory experience in pharmaceutical drug development.
  • Solid working knowledge of drug development process and US regulatory requirements.
  • Demonstrated experience developing and implementing regulatory strategies for US INDs, BLA, and/or NDAs
  • Experience with rare disease drug development.
  • Demonstrated experience successfully operating in a global environment.
  • Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field minimum, with 8 years regulatory experience.
  • Strategic thinker
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance
  • Direct interaction/negotiation experience with US FDA.
  • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
  • Excellent operational skills including planning, organizing and ability to motivate and lead others.
  • Ability to work well within cross-functional globally oriented teams
  • Demonstrates excellent oral communication and writing skills
  • Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology. Ability to understand issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
  • Develops collaborative relationships to facilitate the accomplishment of work goals
  • Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
  • Ability build networks to obtain cooperation without relying on authority
  • Unquestionable ethics, professional integrity, and personal values consistent with the company values

 

DATE POSTED 2019-12-26

Shown below are the latest jobs from this category.

Human Resource Manager

Little Falls, NJ
Job Order: GD-715
       Job Descriptions: In charge of employee relations which includes leading the social and recreation committee, organizing lunches, staff outings and year end parties. Develop other employee relation activities and enhancements. Be the point of contact for any staff related employee relation issues. Conduct “check-in” discussion with new employees...
DATE POSTED 2020-01-23

HR Manager

Attleboro, MA
Job Order: GD-720
Job Descriptions: Serve as a business partner with the on-site management team to effectively manage the Human Resources function while maintaining compliance with industry regulatory agencies and company programs  Administer Staffing, Training, Employee Relations, Safety, Compliance, Benefits, Employee Retention, and Compensation programs at the local level and implement corporate-wide,...
DATE POSTED 2020-01-08

Territory Manager

London, Ontario
Job Order: CT-722
  Job Descriptions: Achieves territory sales objectives in all categories, including new product launches and increasing sales within the assigned territory. Maintains high retention rate of customer base through delivery of outstanding service and through effective analysis of the business needs of the customer. Develops a Monthly Business/Action Plan that supports the needs of their...
DATE POSTED 2019-11-05

Area Sales Manager

Central Florida, San Francisco, New Orleans,Arkansas
Job Order: GD-726
Job Description: Drive the success and growth of your sales region by generating leads vigorously and effectively. Meet with prospective and existing customers to provide product demonstrations and close on all product confidently. Cultivate early customer relationships for all company products. Participate in 3-5 weekly phone calls with Regional Sales Manager, RSM, (call objectives clearly...
DATE POSTED 2019-11-18

Project Manager

Guelph
Job Order: GD-727
Job Description: Proven ability to build strong relationship with internal customers, external customers, leasing agents, property managers, landlords, government agencies, and other stakeholders Excellent written and oral communication skills; ability to communicate appropriately with a variety of stakeholders Excellent organizational skills; ability to work under pressure, prioritize, manage...
DATE POSTED 2019-11-18
Warning

Please, enter a valid value

Thank you.

Your password successfully changed.