9 Regulatory Affairs Manager Jobs in Fort Lauderdale, FL
Scientific Search is Hiring a Regulatory Affairs Manager Near Fort Lauderdale, FL
What You Can Expect To Be Doing
- Supervise and participate in planning, preparing and evaluating regulatory documents for submission to the U.S. Food and Drug Administration (FDA).
- Serve as an informative regulatory resource for cross-functional teams within ADMA.
- Provide regulatory guidance to address FDA questions for both investigational and market product applications.
- Ensure corporate policies, procedures and manufacturing/testing activities comply with regulatory requirements and approved INDs/BLAs.
- Provide accurate and timely regulatory guidance to all company functions while maintaining frequent contact with the Head of Regulatory Affairs.
- Perform other projects, project-based tasks and/or special projects as assigned by senior regulatory management.
- Provide direct or indirect supervision of individuals including mentoring and performance management.
- Ensure corporate policies and company procedures are in full and ongoing compliance with regulatory requirements.
- Serve on project teams to contribute regulatory guidance for investigational and marketed products, regulatory strategy and to ensure that appropriate and feasible strategies are explored. Keeps corporate management and project team members abreast of regulatory submission deadlines and submission status.
- Keep abreast of new laws and regulations and assesses impact on company products and processes. Alerts senior regulatory management of potential regulatory impact and implements appropriate internal changes. Contributes to the development of company policy and company positions on draft regulation and guidance.
- Work closely with Quality Assurance to conduct regulatory risk assessments of quality system documents and practices.
- Utilize problem solving skills to recommend risk mitigation strategies, and to develop alternative courses of action or contingency plans. Oversees the Biological Product Deviation reporting and product recall procedures (including notifications and corrections).
- Oversee Regulatory Operations by developing or maintaining project timelines/milestones/submission tracking systems, and document archive systems. Practices regulatory process improvement by reviewing, writing and revising policies, standard operating procedures (SOP) and work instructions (WI) that ensure efficient and compliant regulatory processes.
- Plan regulatory milestones, sets timelines and assures timely, accurate and complete submissions to regulatory agencies. Advises senior regulatory management of challenges to achieving timely, accurate or complete submissions.
- Determine regulatory strategy that aligns with business strategy, defines submission requirements and coordinates the collection of required data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed.
- Responsible for preparation, review, presentation, and evaluation of all regulatory submissions. Assesses accuracy and completeness of submission documents throughout product lifecycle, specifically pre-application submissions (e.g., meeting requests), new application submissions (e.g., Investigational New Drug applications [IND], Biological License Applications [BLA], maintenance submissions (e.g., end-of-phase reports, annual reports, changes to IND or BLA Common technical Document [CTD] dossier, safety reports, product license renewals, establishment license renewals, meeting requests) and post-marketing submissions (e.g., annual reports, periodic safety reports, annual reports of Post-marketing requirements or commitments), and other related documents or submissions.
7-10 years' experience in Biologic Regulatory Affairs function with FDA, cGMP and cGCP experience. Experience with both personnel and project management. CBER and BLA experience is essential.
If you would like to learn more about this great opportunity, please reach out to Michelle Lair at MichelleL@ScientificSearch.com
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Job Summary
Full Time
Ambulatory Healthcare Services
$93k-120k (estimate)
09/09/2024
10/03/2024
scientificsearch.com
CHERRY HILL, NJ
25 - 50
1983
ALLEN C ZECHOWY MDPHD
<$5M
Ambulatory Healthcare Services
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About Scientific Search
Scientific Search is a leader in the placement of technology professionals. Our technology areas of specialization include engineering, pharmaceutical & biotech, market research and information technology. Our client base is predominately centered in the corridor stretching from Philadelphia to New Jersey and the New York metropolitan area. We do, however, conduct a significant portion of our business outside of our primary market territory, both regionally and nationally. We are a full service employment agency offering multiple staffing options. From contract placements to direct placements ...and everything in between, Scientific Search works with employers and technology professionals to find the perfect solution. Scientific Search was founded in 1983 and has been providing recruiting and staffing excellence for twenty years. We have survived and excelled through a combination of hard work, knowledge and integrity. We are the firm that leading employers depend on to solve their staffing needs, and technology professionals trust to find challenging, rewarding positions. To learn more about Scientific Search, please visit our website at www.scientificsearch.com or call 856-761-0900.
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The job skills required for Regulatory Affairs Manager include Regulatory Affairs, Planning, Commitment, Problem Solving, Quality Assurance, Process Improvement, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Manager positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Manager, it can be promoted into senior positions as a Regulatory Affairs Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Manager. You can explore the career advancement for a Regulatory Affairs Manager below and select your interested title to get hiring information.
If you are interested in becoming a Regulatory Affairs Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Regulatory Affairs Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Regulatory Affairs Manager job description and responsibilities
Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
04/15/2022: Charleston, SC
They will provide responses to regulatory agencies regarding product information or issues.
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They'll establish regulatory priorities or budgets and allocate resources and workloads.
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Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies.
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The position will provide regulatory review, registration and data management, strategic regulatory advice and submissions to appropriate regulatory agencies.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Regulatory Affairs Manager jobs
Having the knowledge and understanding of complex medical and scientific subject matter would give you advantage for this role.
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You need the ability to build networks to obtain cooperation.
03/12/2022: Temple, TX
Manager Regulatory Affairs are able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
04/10/2022: Great Falls, MT
They utilize their technical skills to ensure products remain safe and efficient by meeting all the regulatory standards.
03/28/2022: Lowell, MA
You need to have IT skills, particularly in relation to using databases and familiarity with commercial software to qualify for this role.
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Step 3: View the best colleges and universities for Regulatory Affairs Manager.
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