Regulatory Affairs Specialist Project Lead I - Washington, United States - Aequor Technologies

Aequor Technologies Washington, United States

1 week ago

Part time

Description

Fully Remote
Part-Time Mon - Fri 9 AM - 1 PM EST

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 client's 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 client's products and goals.

Coordinate and lead internal teams to develop client 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 client position.

Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters.
Lead proactive advocacy efforts for client's 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.

Project Lead

2 weeks ago

International Association of Chiefs of Police Washington, United States

Salary: Up to $65,000, Commensurate with Experience · Cover Letter Required: Yes · Type: Non-Profit 501(c)(3) · Closing Date: Monday February 5, 2023 · _________________________________________________________________________ · Are you looking to make a difference? When you ...
Project Lead

2 weeks ago

The MITRE Corporation Washington, United States

Why choose between doing meaningful work and having a fulfilling life? At MITRE, you can have both. That's because MITRE people are committed to tackling our nation's toughest challenges-and we're committed to the long-term well-being of our employees. MITRE is different from mos ...
Project Lead

2 weeks ago

FedWriters Washington, United States

Job Title: Project Lead · Job Summary: · Elevate your career as a Project Lead with a pivotal role at the Defense Intelligence Agency (DIA). You'll be a critical part of the mission to make declassification decisions regarding DIA records, both physical and electronic. · Respo ...
Project lead

2 weeks ago

HCL Technologies Washington, United States

Skills: Site Reliability engineering (SRE)No. of positions: 6To create, assign and track the project [module] work plans for delivery and also provide technical guidance for work completion.To create work plans, monitor and track the work schedule for on time delivery as per the ...
Project Lead

2 weeks ago

HCL Technologies Washington, United States

Job Description (Posting). · 1. SKILLS EXPERIENCE REQUIRED · Education: Bachelor s degree in Computer Science, Information Systems, or Finance · Role Specific Experience: 3+ years of relevant technical and business work experience · Banking Financial domain experience, along ...
IT Infrastructure Project Lead

3 weeks ago

Addison Group Washington, United States

This is an exciting Permanent FULL TIME opportunity to be responsible for overseeing the day-to-day operations of IT infrastructure. This position involves strategic planning, project management, and ensuring the alignment of IT services with the business objectives of the organi ...
Lead Project Manager

6 days ago

Public Consulting Group Washington, United States

OverviewPublic Consulting Group LLC (PCG) is a leading public sector solutions implementation and operations improvement firm that partners with health, education, and human services agencies to improve lives. Founded in 1986, PCG employs approximately 2,000 professionals through ...
Project Manager/Lead

5 days ago

VTG Washington, United States

Overview: · VTG is seeking a full time on-site Project Manager/Lead (ISP Cabling, Audio Visual, and Security) in Washington, DC. · Responsibilities: 100% full time on-site Project Manager for all times we have installation crews or subcontractors on site. · managing ISP cablin ...
Lead Project Engineer

3 days ago

cFocus Software Incorporated Washington, United States

Job Description · Job Description · cFocus Software is seeking a Lead Project Engineer to support a 5-year contract. · Locations: Annapolis Junction, MD, Reston, VA, or Washington, DC (JBAB). · Position Requirements: · TS/SCI w CI Polygraph required · 10+ years of experience ...
Project Manager, Lead

2 days ago

Booz Allen Hamilton Washington, United States

Job Number: R · Project Manager, Lead · The Opportunity: · An effective project requires a manager who is passionate about guiding it through the complexities of its lifecycle. It requires someone who is dedicated to identifying challenges, mitigating risks, and supporting a te ...
Project Manager, Lead

6 days ago

Booz Allen Washington, United States

Project Manager, Lead · The Opportunity: · An effective project requires a manager who is passionate about guiding it through the complexities of its lifecycle. It requires someone who is dedicated to identifying challenges, mitigating risks, and supporting a team with vision a ...
Project Support Lead

2 weeks ago

Pantheon Data Washington, United States

Company Overview · Pantheon Data (a Kenific Holding company) is a private, small business based in the Washington, DC, area. Pantheon Data was founded in 2011, initially providing acquisition and supply chain management services to the US Coast Guard. Our service offerings have ...
Technical Project Lead

13 hours ago

Ampcus Washington, United States

ESSENTIAL DUTIES · For IT initiatives defined as small and medium: · Performs project planning, resourcing and scheduling. · Convenes cross-functional teams and drives project activity to defined milestones and deliverables. · Monitors, tracks, and reports on project schedules. · ...
Project Lead

2 weeks ago

Booz Allen Hamilton Washington, United States

An effective project requires a director who is passionate about guiding it through the complexities of its lifecycle. It requires someone who is dedicated to identifying challenges, mitigating risks, and supporting a team with vision and focus. That Project Lead, Project Managem ...
Project Lead

2 weeks ago

Booz Allen Hamilton Washington, United States

Project Lead · The Opportunity: · An effective project requires a director who is passionate about guiding it through the complexities of its lifecycle. It requires someone who is dedicated to identifying challenges, mitigating risks, and supporting a team with vision and focus ...
Project Lead

2 weeks ago

Bart & Associates Washington, United States

Project Lead · At B&A, we foster and embrace a distinct set of values that we live by and instill in all aspects of our organization: dedication, commitment, partnership, trust, and recognition. We have incorporated these values into successful delivery for our customers since 1 ...
Project Lead

2 weeks ago

Go Intellects Washington, United States

Job Description · Job Description · Benefits: · Competitive salary · Short Description : · Senior Project Lead with proven professional experience in project management, business analysis, systems analysis, user story creation and requirements documentation. · Complete Descr ...
Project Lead

2 weeks ago

FedWriters Washington, United States

Job Title: Project LeadJob Summary:Take on a pivotal role at the forefront of national security as a Project Lead with the Defense Intelligence Agency. In this critical position, you'll spearhead efforts to declassify sensitive DIA records, both physical and electronic, ensuring ...
Project Lead

2 weeks ago

Integral Consulting Services Washington, United States

OverviewProject LeadLocation: National Capital RegionClearance: Active TS/SCIThe Project Lead produces cost data, specifically the top-level cost of the Agile team over time, software costs, hardware costs, cloud service and computing (including bandwidth and storage costs), lice ...
Project Lead

2 weeks ago

Booz Allen Hamilton Washington, United States

Project LeadThe Opportunity:An effective project requires a director who is passionate about guiding it through the complexities of its lifecycle. It requires someone who is dedicated to identifying challenges, mitigating risks, and supporting a team with vision and focus. That's ...