Regulatory Affairs Specialist Project Lead - Washington, United States - Lee Hecht Harrison Nederland B.V.

Lee Hecht Harrison Nederland B.V. Washington, United States

3 weeks ago

Description

Fully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for different time zones)

Candidates must be located in the US w/possibility of extensionCompensation:
$ $91.00/hrMust

Have Skills: 3 6 years of related experience in a pharma regulatory related role open all therapeutic areas (not manufacturing), non CMC experience Open to previous Sr.

or Leadership exp Fluent with online searches/ research MS Office - Excel, PowerPoint Ability to create decks/ presentationsNice to

Have Skills:
Writing, analyzing data, write-ups of research/ searches

SCOPE OF RESPONSIBILITIES:
accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision-making working across teams

DUTIES:
Work with regulatory leads through cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, FDA engagement, and other external engagement efforts Ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods, and medical devices)

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 the 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 Sanofi 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.

Ability 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.

Pay Details:
$89.00 to $91.00 per hourSearch managed by: Lauren LittenBenefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

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