26 Regulatory Affairs Specialist Project Lead Jobs in Washington, DC
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US Development Finance Corporation (formerly...
Washington, DC | Full Time
$71k-87k (estimate)
1 Month Ago
F
Regulatory Affairs Specialist Project Lead
$90k-117k (estimate)
Full Time
4 Days Ago
Cynet Systems is Hiring a Regulatory Affairs Specialist Project Lead Near Washington, DC
Job Description:
Responsibilities:
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.
- 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
06/22/2024
EXPIRATION DATE
07/09/2024
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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