Top Regulatory Affairs Executive jobs in Utica, NY
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
Principal Regulatory Affairs Consultant
- 1010 Parexel International, LLC
-
Maryland, NY
FULL_TIME
- When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel’s Regulatory Compliance team is known for our unparalleled breadth and depth of expertise globally. Parexel Regulatory Compliance offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world, and we are growing! We currently have a home-based opening on our Strategic Regulatory Compliance Team for a an experienced GMP Compliance Expert to join the team as a Principal Consultant. This is an incredible opportunity to assist pharmaceutical and biopharmaceutical companies in driving quality; help our clients manage and prepare for FDA GMP inspections and manage post inspection activities; and work alongside some of the best and most experienced regulatory compliance professionals. A truly phenomenal opportunity to apply your expertise while continuing to develop your career! A Principal Consultant will have the knowledge and ability to provide clients with recommendations on how to bring their processes and procedures into compliance with cGMPs and industry best practices; the ability to write clear, concise, objective reports and recommendations; and effectively communicate and interact with our clients at all levels within their organization. To be successful a Principal Consultant will have specialized experience in the following: Pre-approval and pre-licensing sterile inspection experience Experience conducting inspections which have resulted in FDA-483 Inspectional Observations and subsequent OAIs and/or Warning Letters Experience in the following areas is a plus: Preparation of written responses and remediation plans to address FDA-483 Inspectional Observations and Warning Letters Providing on-site guidance during FDA inspections Preparation for Discussion of Regulatory Compliance Matters with FDA Playing an active role in Compliance Remediation strategy and implementation Conducting specialized GMP training Education: PhD in a in a scientific discipline or other advanced degree or equivalent in engineering is highly preferred with 12 years of GMP experience. Previous experience conducting sterile facility inspections is required. Knowledge and Experience: Previous Industry experience in Quality and/or Compliance or previous experience as a Consumer Safety Officer with a regulatory agency (such as FDA, MHRA) is strongly preferred. Strong regulatory knowledge is required. Skills: High-level consulting skills Critical thinking and problem-solving skills Project leadership and management knowledge Excellent interpersonal and intercultural communication skills, both written and verbal Meticulous attention to detail and the ability to spot issues. Client-focused approach to work Results orientation Teamwork and collaboration skills Proficiency in local language and extensive working knowledge of the English language Proactive Networking Business acumen and analysis Self-confidence and control Up to 70% Domestic and International Travel Required EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.
- 1 Month Ago
Vice President, Technical / Clinical Regulatory Affairs SME - Oncology
- 1010 Parexel International, LLC
-
Maryland, NY
FULL_TIME
- When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market acces...
- 1 Month Ago
Junior Project Management Analyst
- Tip Top Recruiting LLC
-
Maryland, NY
FULL_TIME
- Job Description:Provide project management support to the Integrated Command & Control and Intelligence Systems (IC2&IS) Division at Webster OutLying Field (WOLF) in the initiating, planning, executin...
- 10 Days Ago
Project Management Analyst
- Tip Top Recruiting LLC
-
Maryland, NY
FULL_TIME
- Job Description:Provide project management support to the Joint Simulation Environment (JSE) at Patuxent River in the initiating, planning, executing, monitoring & controlling, and closing of projects...
- 10 Days Ago
Senior Regulatory Specialist
- Stantec
-
Maryland, NY
FULL_TIME
- Senior Regulatory Specialist - ( 240000FL ) Description Grounded in safety, quality, and ethics, our experts lead their fields and guide our work with rigor, a creative spirit, and vision for growth. ...
- 22 Days Ago
Chief Estimator
- Blue Ridge Executive Search
-
Vernon, NY
FULL_TIME
- Chief Estimator-New York City, New York We are looking for a Chief Estimator to head our building group. Projects are in the Greater New York City Area, and the ideal candidate will possess extensive ...
- 7 Days Ago
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0 Top Regulatory Affairs Executive jobs found in Utica, NY area
Clinician / Licensed Mental Health Therapist - LMSW/LMHC/LMFT
- A dynamic organization dedicated to improving the lives of individuals and families.
-
Utica, NY
- Job Description Job Description Competitive Salary and Excellent Benefits + $5,000 Sign-On Bonus! A leading provider of ...
- 4/24/2024 12:00:00 AM
SIU Investigator
- Delta Group
-
Utica, NY
- Job Description Job Description Salary: $30 - $40 an hour DOE Delta Group is a privately held, woman-owned, national inv...
- 4/23/2024 12:00:00 AM
Chief Financial Officer
- Express Employment Professionals Utica/Rome
-
Utica, NY
- Premier company is seeking a Chief Financial Officer who will be responsible for financial strategy, financial planning ...
- 4/22/2024 12:00:00 AM
Pharmacist Floater
- Price Chopper Supermarkets-Market 32
-
Utica, NY
- Overview Administers a process of dispensing of medication to patients pursuant to a valid prescription with the highest...
- 4/22/2024 12:00:00 AM
Store Clerk
- KPH Healthcare Services
-
Clinton, NY
- Overview: Scope of Responsibilities: Works under direct supervision and follows standard procedures to accomplish assign...
- 4/22/2024 12:00:00 AM
Internal Revenue Agent (Examiner) - Direct Hire, 12 Month Register AMENDED
- Department Of The Treasury
-
Utica, NY
- Duties WHAT ARE THE APPEALS (AP), LARGE BUSINESS AND INTERNATIONAL (LB&I), SMALL BUSINESS SELF-EMPLOYED (SB/SE) AND TAX ...
- 4/22/2024 12:00:00 AM
Pharmacist Floater
- Price Chopper Supermarkets-market 32
-
Utica, NY
- OverviewAdministers a process of dispensing of medication to patients pursuant to a valid prescription with the highest ...
- 4/21/2024 12:00:00 AM
Controller
- Würth MRO, Safety, & Metalworking
-
Frankfort, NY
- Looking for an analytical and numbers focused professional. Wurth Industry has the perfect career opportunity for you! W...
- 4/20/2024 12:00:00 AM
About Utica, New York
Utica (/ˈjuːtɪkə/ (listen)) is a city in the Mohawk Valley and the county seat of Oneida County, New York, United States. The tenth-most-populous city in New York, its population was 62,235 in the 2010 U.S. census. Located on the Mohawk River at the foot of the Adirondack Mountains, Utica is approximately 95 miles (153 kilometers) northwest of Albany, 55 mi (89 km) east of Syracuse and 240 miles (386 kilometers) northwest of New York City . Utica and the nearby city of Rome anchor the Utica–Rome Metropolitan Statistical Area, which comprises all of Oneida and Herkimer counties.
Formerly a rive...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$287,646 to $470,597
Utica, New York area prices
were up 1.5% from a year ago
were up 1.5% from a year ago
What does a Top Regulatory Affairs Executive do?
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