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Regulatory Affairs Specialist Project Lead
Cynet Systems Washington, DC
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$90k-117k (estimate)
Full Time 6 Days Ago
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Cynet Systems is Hiring a Regulatory Affairs Specialist Project Lead Near Washington, DC

Job Description:

Responsibilities:
  • Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact R&D pipeline, regulatory strategy or product portfolio.
  • Provide relevant ad hoc regulatory intelligence to internal stakeholders.
  • Effectively communicate impact and bring awareness of business-critical issues for informed decision making, and work with subject matter experts within the company to assess impact on products and goals.
  • Coordinate and lead internal teams to develop responses and comments on draft legislation, regulations, guidelines and regulatory policies issues.
  • Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to facilitate regulatory input and overall alignment on position.
  • Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters.
  • Lead proactive advocacy efforts for priority regulatory policy areas.
  • Consult with internal experts and leadership to identify priority issues.
  • In collaboration with internal experts and stakeholders, coordinate company policy positions across stakeholder groups, identify or create opportunities for engagement with regulatory authorities and trade associations, and execute on proposed strategies.
Education, Experience and Skill Requirement:
  • Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent preferred
  • Minimum 3 years in Regulatory Affairs.
  • Established regulatory experience.
  • Effective collaboration.
  • Familiarity and understanding of the drug/biologic development and commercialization process.
  • Excellent written, oral, and presentation communication skills Excellent command of English (written and spoken).
  • Superior time management and organizational skills.
  • bility to lead multiple complex initiatives (short, mid and long-term).
  • Self-motivated, prone to action and results oriented.
  • Provides an engaging and motivating work environment.

Job Summary

JOB TYPE

Full Time

SALARY

$90k-117k (estimate)

POST DATE

05/28/2024

EXPIRATION DATE

06/15/2024

WEBSITE

cynetsystems.com

HEADQUARTERS

ARCOLA, VA

SIZE

500 - 1,000

FOUNDED

2010

CEO

ASHWANI MAYUR

REVENUE

$50M - $200M

INDUSTRY

IT Outsourcing & Consulting

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