Regulatory Affairs Specialist jobs in Daytona Beach, FL
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
Director, US Regulatory Affairs & Global
- System One
-
De Land, FL
CONTRACTOR
-
Position: CONTRACTOR -- Director, US Regulatory Affairs & Global Development Projects (GDP)
Location: Remote (East or Central Time Zone) / Prefers local
Contract: 12mns
Pay Rate: 80/hr - 95/hr
Purpose and Scope of Position
The Director, US Regulatory Affairs & Global Development Projects (GDP) is responsible for providing strategic leadership and oversight of all U.S. regulatory activities for assigned products. This role is responsible for ensuring compliance with FDA regulations and guidelines driving regulatory strategies and facilitating successful interactions with regulatory authorities. Additionally, this role provides strategic regulatory guidance and support to our global programs, with a specific focus on US regulatory requirements.
The Director, US Regulatory Affairs & Global Development Projects is responsible for developing and executing robust regulatory strategies that align with the overall business objectives, ensuring compliance with FDA regulations and optimizing the regulatory pathway for product approvals and launches. This role oversees the preparation, review, and submission of regulatory filings to the FDA, including INDs, NDAs, BLAs and other relevant submissions. Ensures accuracy, completeness, and timeliness of submissions to facilitate regulatory approvals. Establishes and maintains processes and systems to ensure ongoing compliance with FDA regulations, guidelines, and requirements. Collaborates with cross-functional and regional teams to drive adherence to regulatory requirements throughout the product lifecycle. Serves as primary point of contact and liaison with FDA representatives and other regulatory authorities. Facilities regulatory agency meetings, addressing inquiries, and leading interactions to ensure effective communication and collaboration. Partners closely with R&D, Clinical, Quality and Manufacturing colleagues to provide regulatory guidance and ensure alignment of regulatory strategies with business goals and objectives. Prepares and coordinates for regulatory inspections and audits. Develops and implements strategies to address findings and ensure timely resolution of any compliance issues. Lastly, this role is responsible for building and maintaining a high-performing regulatory affairs team providing mentorship, coaching, and professional development opportunities to team members. Fosters a collaborative and growth minded culture to support success of team.
Requirements- Bachelor’s degree in a scientific discipline (advanced degree preferred).
- Minimum of 10 years’ experience in US Regulatory Affairs within the pharmaceutical or biotechnology industry. Direct CDER experience preferred. RAC certification preferred.
- Possess a deep understanding of FDA/ICH regulations, guidelines, and regulatory processes across various product types (i.e .drugs, biologics) and ex-US requirements ensuring ongoing compliance with FDA/ICH regulations, guidelines and current Good Manufacturing Processes (cGMP).
- Adept at establishing processes and systems to drive regulatory requirements throughout the lifecycle.
- Demonstrated proficiency in preparing, reviewing, and submitting regulatory filings to the FDA, including INDs, NDAs, BLAs, and other relevant submissions ensuring accuracy, completeness, and timeliness of submissions.
- Exhibit strong capabilities in managing interactions with regulatory authorities, including leading meetings, addressing inquiries, and facilitating communication and collaboration.
- Possess strong project management skills to prioritize and manage multiple projects simultaneously, while meeting deadlines. Coordinating regulatory activities with cross-functional and regional teams to ensure timely execution of regulatory deliverables.
- Demonstrate a meticulous attention to detail when reviewing regulatory submissions, documentation, and compliance-related materials ensuring accuracy and compliance.
- Proven ability to think strategically and develop robust regulatory strategies that align with the business objectives. Anticipating regulatory challenges, opportunities, and providing innovative solutions to drive product success.
- Exhibit strong leadership skills to effectively lead and manage a regulatory affairs team providing mentorship, guidance, and support to team members, fostering a collaborative growth culture.
- Possess excellent communication and influencing skills to effectively collaborate within all levels of the organization- internal stakeholders, cross-functional and regional teams and external stakeholders such as regulatory authority, vendors, CROs, etc.
- Demonstrates exceptional cultural agility and sensitivity, effectively collaborating, adapting and communicating with international colleagues, understanding their business operations, communication styles, and decision-making processes.
- Ability and willingness to travel domestically and internationally up to 20% of the year to attend meetings, conferences, and engaging with regulatory authorities and stakeholders.
- Other duties as assigned.
- Recent responsibilities within the infectious disease, oncology and/or pain therapeutic areas.
- Experience with eCTD submission software useful, but not required.
Responsibilities:- Direct and coordinate activities of assigned products within Regulatory Affairs encompassing developmental products and post-marketing commitments.
- Function as the primary contact for negotiations and interactions with the FDA and offer guidance and strategy to ex-US strategy and filings.
- Contribute to developing regulatory strategies to ensure the shortest FDA review and approval times for regulatory applications.
- Provide regulatory guidance to team during the course of strategy formulation and submission preparation.
- Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to FDA standards for all regulatory submissions.
- Author (when applicable) and maintain IND and NDA applications, supplements and annual reports pertaining to on-going application maintenance in accordance with established timelines and submission dates.
- Liaison with regulatory agencies on product-related regulatory issues. Schedule, participate in, and prepare briefing documents for face-to-face meetings and teleconferences with health authorities.
- Critically review protocols, data and reports to ensure the clarity, consistency, and conformance to regulations, guidelines and regulatory strategy as well as suitability for submission to regulatory agencies.
- Assist with departmental policy and procedure development and implementation. Ensure adherence to Company Standard Operating Procedures. Review and assess Company’s change controls with respect to regulatory requirements.
- Prepare and submit reports to senior management, as required.
- Offer regulatory evaluation and opinions on due diligence activities and provide regulatory assessment to management.
- Other duties as assigned.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
- 18 Days Ago
Regulatory Specialist
- Medical Research Group of Central Florida
-
Orange, FL
PART_TIME
- Job Description:We are seeking a highly organized and detail-oriented part-time Regulatory Specialist to join our team. The Regulatory Specialist will be responsible for managing all aspects of regula...
- 14 Days Ago
Registered Nurse (RN)
- FLORIDA DEPARTMENT OF VETERANS AFFAIRS
-
Daytona Beach, FL
FULL_TIME,PART_TIME,TEMPORARY
- POSITION DESCRIPTION: The incumbent is responsible for giving ordered treatments, administer prescribed medications, give direct ADL care and complete requirements for diagnostic procedures as request...
- 24 Days Ago
Regulatory Research Assistant
- Alpha Clinical Research Centers, LLC
-
Orange, FL
FULL_TIME
- Responsibilities: EDC (Electronic Data Capture) entry of Subject Visits Answering Queries in EDC as needed. Sending the disks and Vendor equipment as per sponsor requirement Updating Regulatory for SI...
- 26 Days Ago
Associate Dean of Academic Affairs
- Florida Technical College
-
De Land, FL
FULL_TIME
- Responsible for the oversight and coordination of all the programs and activities that support student recruitment, education, retention including reentries at the college and the campuses assigned. P...
- 11 Days Ago
Associate Dean of Academic Affairs
- National University College
-
De Land, FL
FULL_TIME
- Responsible for the oversight and coordination of all the programs and activities that support student recruitment, education, retention including reentries at the college and the campuses assigned. P...
- 12 Days Ago
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0 Regulatory Affairs Specialist jobs found in Daytona Beach, FL area
Safety Manager
- Hiring Now!
-
Daytona Beach, FL
- Our client is currently seeking a REGIONAL SAFETY MANAGER in the Orlando, FL area.As a Regional Safety Manager, your pri...
- 4/17/2024 12:00:00 AM
Assistant Branch Manager - Ormond Beach
- Southstatebank
-
Ormond Beach, FL
- ** Assistant Branch Manager - Ormond Beach** **Job Category****:** Branch Manager **Requisition Number****:** ASSIS00866...
- 4/16/2024 12:00:00 AM
Experienced Sales Representative - Energy Services 2
- Rubicon Energy
-
Port Orange, FL
- Job Description Job Description Experienced Sales Representative - Energy Services Company Overview: We are a leading re...
- 4/16/2024 12:00:00 AM
Experienced Endoscopy Tech for ASC in Port Orange - Uncertified
- AdventHealth Surgery Center Port Orange/ Ormond Beach
-
Port Orange, FL
- Job Description Job Description GENERAL SUMMARY: Under supervision, an Endoscopy technician assists with the patient car...
- 4/16/2024 12:00:00 AM
TECHNICAL DOCUMENTATION WRITER
- Thompson Pump
-
Port Orange, FL
- Job Description Job Description Summary: Prepare instruction manuals, how-to guides, journal articles, and other support...
- 4/16/2024 12:00:00 AM
Apartment Leasing Manager
- ConcordRENTS
-
Daytona Beach, FL
- Job Description Job Description BASIC PURPOSE: Performs functions to manage and participate in the implementation of the...
- 4/14/2024 12:00:00 AM
Recovery Reimbursement Analyst
- Halifax Health
-
Daytona Beach, FL
- Overview Halifax Health is seeking a Recovery and Reimbursement Analyst. Summary This individual serves as an operationa...
- 4/14/2024 12:00:00 AM
Hospice RN Executive Director
- Gentiva Hospice
-
Daytona Beach, FL
- Our Company: Gentiva Hospice is a member of the Gentiva family – an industry leader in hospice, palliative, home health,...
- 4/3/2024 12:00:00 AM
About Daytona Beach, Florida
Daytona Beach is a city in Volusia County, Florida, United States. It lies about 51 miles (82.1 km) northeast of Orlando, 86 miles (138.4 km) southeast of Jacksonville, and 242 miles (389.5 km) northwest of Miami. In the 2010 U.S. Census, it had a population of 61,005. It is a principal city of the Deltona–Daytona Beach–Ormond Beach metropolitan area, which was home to 600,756 people as of 2013. Daytona Beach is also a principal city of the Fun Coast region of Florida.
The city is historically known for its beach where the hard-packed sand allows motorized vehicles to drive on the beach in res...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$68,966 to $92,426
Daytona Beach, Florida area prices
were up 1.5% from a year ago
were up 1.5% from a year ago
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020