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Job Details

Regulatory Affairs Associate (Operations, eCTD, Publishing & Formatting)

Company: RBW Consulting
Location: Waltham, MA
Reference: RAA-RAA-WMA
Closing Date: 10 Dec 17
Type: Full Time
Salary (£): 80,000 - 100,000
Benefits: Competitive Benefits Package

Job Summary:

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 617 982 1238 today!

Requirements:

Regulatory Affairs Associate (Operations, eCTD, Publishing & Formatting)

Waltham, MA

Technical Competencies:

  • Knowledge of the pharma Regulatory Affairs discipline throughout the product lifecycle, including Chemistry, Manufacturing, and Controls (CMC), Promotion and Advertising, Labeling, Change Control, etc.
  • Knowledge of US laws, regulations, and guidance’s that affect assigned devices
  • Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate to product development and labeling regulatory activities for assigned devices
  • Ability to influence and partner with cross-functional teams
  • Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
  • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks

Professional Competencies:

  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Strong capability to contribute and lead in a team environment
  • Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
  • Excellent communication skills; both oral and written
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner through technical excellence and mutual respect
  • Demonstrated ability to contribute to a continuous learning and process improvement environment
  • Capacity to react quickly and decisively in unexpected, fluid situations
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
  • Focused ability to influence operational excellence and performance metrics
  • A risk averse nature when needed, with the ability to identify potential solutions to complex problems

Experience and Required Skills:

  • 2 – 5 years of experience in a Regulatory Affairs environment; 2+ years in pharmaceutical industry.
  • Experience with Document Management a plus.
  • Understanding of document management processes in a regulated pharmaceutical/device environment.
  • Demonstrated ability to work to manage projects as part of a team.
  • Must be highly proficient in MS Office (emphasis on MS Word), Adobe Acrobat (version 5.0 or higher).
  • Hands on experience with document management systems.
  • Knowledge of EDM, RIM and electronic publishing software preferred. Experience with electronic submissions, specifically eCTD, or eCopy a plus.
  • Outstanding interpersonal and communication (written and verbal) skills.
  • Detail oriented, proactive, effective task planning and coordination of activities.
  • Strong software troubleshooting skills highly desirable.
  • Experience with Adobe, desktop publishing software, document management solutions, database software and Microsoft Office.
  • Detail oriented; ability to work under deadlines; strong organizational skills required.

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 617 982 1238 today!

Apply for this job: Regulatory Affairs Associate (Operations, eCTD, Publishing & Formatting)

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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