Sr. Manager Regulatory Affairs - Class III Aesthetics - $155K

Santa Barbara  ‐ Onsite
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Keywords

Description

This position is responsible for global management of at least one major operational component of submission production, maintenance processes, and/or Information Management in support of the company's product portfolio. This position will also independently develop, implement, maintain and manage the strategy for areas of responsibility in alignment with the global Regulatory strategy.

Participate in due diligence activities as a representative of Regulatory Affairs, in partnership with Business Development. Provide advice on the regulatory status and probability of success of potential projects for in-licensing.

Desired Skills and Experience
  • Minimum of a Bachelor's degree or country equivalent in pharmacy or related scientific, information management, or computer science with a minimum of 11 years regulatory or equivalent experience or an Advanced degree with a minimum of 9 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.
  • Sound basis of regulatory knowledge specific to advertising and promotion of drugs, devices and cosmetics.
  • Ability to manage complex projects and timelines in a matrix team environment with the ability to lead and coach others.
  • Excellent analytical and communication skills both verbal and written.
  • Excellent interpersonal skills with strong negotiation skills for diplomatic interaction with clinical research, Sales and Marketing personnel and outside contacts.
  • Excellent computer skills required.
  • Excellent written and verbal communication, presentation, negotiation and facilitation skills
  • Expert knowledge of regulations within multiple regions, and experience with interpretation and application
  • Proven analytical skills with the ability to evaluate needs and develop and implement effective solutions independently
  • Expert knowledge, experience with evaluation, implementation, and validation of relevant industry available software and hardware (e.g., scanners, printers, MS Office, ARGUS, Business Objects, Documentum, First Docs, Insight Manager, Insight Publisher, CoreDossier, ISI Toolbox).
  • Risk identification and problem-solving skills
  • Demonstrated ability to lead, mentor, and develop others for future growth and development
  • Established relationships with regulatory authorities
  • Ability to travel


To find out more about Real please visit www.realstaffing.com
Start date
12/2014
From
Real Staffing
Published at
09.11.2013
Project ID:
624897
Contract type
Permanent
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