Top Regulatory Affairs Executive jobs in New York
Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Recently Added Top Regulatory Affairs Executive jobs
Regulatory Affairs Executive Director
- DK06 (FCRS = DK006) Novartis Healthcare A/S
-
Copenhagen, NY
FULL_TIME
- Job Description Summary -Provides strategic direction to teams to achieve registration and drives preparation and submission of regulatory documentation. Interacts and negotiates with regulatory agencies in order to expedite competitive approval of pending registration applications and serves as a regulatory liaison on the project team(s) throughout the product lifecycle. Ensures timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Coordinates and reviews preparation of regulatory submissions, including preparation of specific regulatory components. Job Description Major accountabilities: typically within the assigned franchise and/or therapeutic areas or assigned region(s)/country(s) -Ensures high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans -Ensures high quality and professional interactions with HAs globally including participation in key formal and informal HA contacts as required -Ensures compliance with global regulatory requirements and adherence to internal policies and processes and coordinate compliance activities at a global level -Leads and supervises assigned regulatory liaisons including performance management, in collaboration with the global line functions -Ensures synergy where appropriate across the group of projects at a global level -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely preparation of high quality regulatory documents -Health Authority issues and major issues with cross functional impact are appropriately highlighted -Quality of HA interactions at appropriate time points during development with excellent negotiation skills -Fulfill regulatory responsibilities for assigned projects and achieve registration -Adherence to Novartis policy and guidelines Minimum Requirements: Work Experience: People Challenges. Critical Negotiations. Strategy Development. People Leadership. Collaborating across boundaries. Representing the organization. Skills: Cross-Functional Teams. Drug Development. Global Clinical Trials. Lifesciences. Negotiation Skills. People Management. Problem Solving Skills. Program Management. Regulatory Compliance. Risk Management. Strategy. Languages : English. Skills Desired Cross-Functional Teamwork, Drug Development, Global Clinical Trials, Group Problem Solving, Life Science, Negotiation, People Management, Program Management, Regulatory Compliance, Risk Management, Strategy Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. We also aim to reward those who invest their money, time and ideas in our company.
- 13 Days Ago
Vice President of Biologics and ATMP Regulatory Affairs
- Get It Recruit - Executive
-
New York, NY
FULL_TIME
- Join a Leading Organization in Pioneering Research and DevelopmentOur organization is dedicated to driving innovation in research and development to deliver life-changing therapies to patients worldwi...
- 7 Days Ago
Account Executive (SaaS)
- Regulatory DataCorp Career Center
-
New York, NY
FULL_TIME
- We are seeking an experienced Account Executive to join our growing sales organization. In this role, you will be responsible for driving revenue growth by securing new customers in mid/large financia...
- 1 Day Ago
Associate Manager, Executive and Stakeholder Communications
- Financial Industry Regulatory Authority, Inc.
-
New York, NY
FULL_TIME
- Corporate Communications is responsible for planning and implementing proactive communications on major initiatives; working to promote positive, accurate and fair media coverage of FINRA; and promoti...
- 18 Days Ago
Regulatory Affairs Specialist
- Henry Schein
-
Melville, NY
FULL_TIME
- This position is responsible to acquire/maintain/audit company licensing and product registration. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the co...
- 3 Days Ago
Regulatory Affairs Coordinator
- Charles B. Wang Community Health Center
-
New York, NY
FULL_TIME
- Full-Time Regulatory Affairs CoordinatorReports To: Director of Compliance, Risk, and Regulatory AffairsFlushing Queens/Lower ManhattanNew YorkUnited StatesResponsibilitiesDay-to-day management of the...
- 3 Days Ago
Top Regulatory Affairs Executive jobs at Popular Companies
Regulatory Affairs Specialist
- Alphatec Spine
-
Carlsbad, CA
- Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Planet Pharma
-
- Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Astrix
-
Fort Worth, TX
- Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Highridge Medical
-
Westminster, CO
- Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
- 6/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- CM Medical Recruitment
-
- CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
- 6/8/2024 12:00:00 AM
Sr. Specialist, Regulatory Affairs
- Alphatec Spine
-
Carlsbad, CA
- The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and interna...
- 6/8/2024 12:00:00 AM
Regulatory Affairs Specialist
- Net2Source Inc.
-
Palo Alto, CA
- Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
- 6/7/2024 12:00:00 AM
About New York
New York is a state in the Northeastern United States. New York was one of the original thirteen colonies that formed the United States.
New York covers 54,555 square miles (141,300 km2) and ranks as the 27th largest state by size.[3] The highest elevation in New York is Mount Marcy in the Adirondacks, at 5,344 feet (1,629 meters) above sea level; while the state's lowest point is at sea level, on the Atlantic Ocean.
In contrast with New York City's urban landscape, the vast majority of the state's geographic area is dominated by meadows, forests, rivers, farms, mountains, and lakes. Most of...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$313,837 to $513,433
Most Popular Cities in New York for Top Regulatory Affairs Executive Jobs
What does a Top Regulatory Affairs Executive do?
Top Regulatory Affairs Executive in Wilmington, NC
On average, a Doctorate Degree is the highest level of education for a Top Regulatory Affairs Executive.
February 04, 2020
Top Regulatory Affairs Executive in Champaign, IL
If you were hiring a person for this job As Top Regulatory Affairs Executive, what would you look for.
February 06, 2020
Top Regulatory Affairs Executive in Boca Raton, FL
During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020