Regulatory Affairs Director jobs in North Carolina

Regulatory Affairs Director oversees regulatory matters and executes the 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 Regulatory Affairs Director 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, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Director, Regulatory Affairs
  • Octapharma Plasma, Inc.
  • Charlotte, NC FULL_TIME
  • How to Maximize
    your opportunity to do rewarding work,
    your future leadership potential,
    and your career growth?


    Join an Industry Leader
    [Become one, too!]


    Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role:

    Director, Regulatory Affairs

    This Is What You’ll Do:

    • Interpret regulations and guidance documents in order to advise Octapharma Plasma, Inc. (OPI) management team on the business impact of current regulatory requirements.
      • Assembles regulatory requirements and related white papers.
      • Researches all regulations relative to OPI processes.
      • Provides recommendation on changes to OPI SOPs/processes in order to comply with regulatory guidance and inspection observation.
      • Direct the Corporate Audit Team and oversee the development of reporting tools to monitor audit activities.
      • Mentor Corporate Audit Team regarding best audit practices and audit demeanor according to company expectations.
      • Serve as the Regulatory representative to the Change Control Board. Review / develop change control requests and assess impact against regulatory compliance.
        • Monitor trends to recommend CAPA plans for all audit activities, and report to senior management regarding process improvement opportunities.
      • Develop system to evaluate all regulations periodically for changes that may impact the organization:
        • FDA and EU.
        • CLIA, PPTA and OSHA.
        • State.
        • Local (including any public health reporting requirements).
        • Biohazard waste.
        • Licensure for physician substitutes and/or moderate/high-complexity testing staff.
      • Lead the preparation and review of regulatory submissions registration/licensure packages to ensure effective data presentation and quality.
      • Develop and implement tracking process for all facility licenses and related regulatory submissions.
      • Serve as Alternate FDA Authorized Official in order to manage the processes to achieve regulatory agency input regarding approved products.
      • Present regulatory data needs, negotiate with and influences management, colleagues and partners to ensure regulatory data requirements are met. Propose and develop new/revised policies and procedures to support regulatory compliance.
      • Develop systems to ensure regulatory compliance, and strive to ensure that products remain in compliance.
        • Provide guidance to ensure process streamlining occurs.
      • Serve as the Regulatory Affairs representative on cross-functional teams.
        • Consultant to the Risk Management Team and Legal cases, where applicable.
        • Consultant to HR for regulatory requirements related to hiring.
      • Serve as the OPI Regulatory Affairs representative to organizations related to the plasma industry.
        • Attend meetings to obtain information on upcoming changes to equipment, processes and regulations.
        • Provide input to and attends focus groups allowing OPI input into the changing needs of the plasma industry.

      This Is What It Takes:

      • Bachelor’s degree or ten (10) years’ experience in an allied health environment with an emphasis in quality and/or compliance management.
      • Seven (7) years’ job related experience in a biologics, drug manufacturing, medical device facility or FDA regulated environment.
      • Five (5) year supervisory experience, preferred.
      • Demonstrated knowledge of cGMPs FDA regulations, SOP implementation, as well as an understanding of quality assurance principles and audit functions.
      • Certified Quality Auditor CQA (ASQ), preferred.
      • Demonstrated excellent interpersonal, written, and verbal communication skills.
      • Demonstrated decision-making ability and ability to positively influence / manage people.
      • Demonstrated ability to work independently.
      • Demonstrated experience working with all levels in an organization.

      Do Satisfying Work. Earn Real Rewards and Benefits.

      We’re widely known and respected for our benefits and for leadership that is supportive and hands-on.

      • Formal training
      • Outstanding plans for medical, dental, and vision insurance
      • Health savings account (HSA)
      • Employee assistance program (EAP)
      • Wellness program
      • 401 (k) retirement plan
      • Paid time off
      • Company-paid holidays
      • Personal time

      More About Octapharma Plasma, Inc.

      With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.

      INNER SATISFACTION.

      OUTSTANDING IMPACT.

  • 19 Days Ago

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Associate Director, Regulatory Affairs
  • Mayne Pharma
  • Raleigh, NC FULL_TIME
  • Position Overview: This position reports to the Vice President, Regulatory Affairs and Quality and has the overall responsibility for managing pre and post marketing regulatory activities for all comp...
  • 11 Days Ago

D
Director, Regulatory Affairs
  • Default Board
  • Charlotte, NC FULL_TIME
  • How to Maximizeyour opportunity to do rewarding work,your future leadership potential,and your career growth? Join an Industry Leader[Become one, too!] Octapharma Plasma offers professional opportunit...
  • 18 Days Ago

M
Director, Regulatory Affairs
  • Merz Therapeutics
  • Raleigh, NC FULL_TIME
  • Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take a nurturing approach to our organization – treating colleagues like family, embracing our whole selves and creating a co...
  • 1 Month Ago

M
Associate Director / Director, Regulatory Affairs
  • Merz Therapeutics
  • Raleigh, NC FULL_TIME
  • Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take a nurturing approach to our organization – treating colleagues like family, embracing our whole selves and creating a co...
  • 22 Days Ago

M
Associate Director / Director, Regulatory Affairs
  • Merz Pharmaceuticals, LLC
  • Raleigh, NC FULL_TIME
  • Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take a nurturing approach to our organization – treating colleagues like family, embracing our whole selves and creating a co...
  • 9 Days Ago

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Head of Regulatory Affairs
  • The Judge Group
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 3/28/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Catalyst Life Sciences
  • Lowell, MA
  • Catalyst Life Sciences is partnered with a medical device company seeking an experienced leader in international regulat...
  • 3/28/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Atrium Medical
  • Hudson, NH
  • Position Specific Requirements: Responsible for internal, domestic, and international compliance activities working unde...
  • 3/27/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Solari Enterprises, Inc.
  • Orange, CA
  • Job Description Job Description Join Our Team Today—We Are Growing! Position Overview: Solari Enterprises, Inc. is curre...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • The Judge Group
  • Horsham, PA
  • Regulatory Affairs Specialistreq38824Employment Type: RegularLocation: HORSHAM,PAHave you ever enjoyed Arnold, Brownberr...
  • 3/26/2024 12:00:00 AM

A
Director of Regulatory Affairs
  • Addison Group
  • Pasadena, TX
  • Summary: Marine Regulatory Director will direct and oversee marine permit applications and support through providing sub...
  • 3/24/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Kelly Science, Engineering, Technology & Telecom
  • Gaithersburg, MD
  • Description: Director Regulatory Affairs, Late Cardiovascular, Renal and Metabolism Are you passionate about science and...
  • 3/24/2024 12:00:00 AM

North Carolina (/ˌkærəˈlaɪnə/ (listen)) is a state in the southeastern region of the United States. It borders South Carolina and Georgia to the south, Tennessee to the west, Virginia to the north, and the Atlantic Ocean to the east. North Carolina is the 28th-most extensive and the 9th-most populous of the U.S. states. The state is divided into 100 counties. The capital is Raleigh, which along with Durham and Chapel Hill is home to the largest research park in the United States (Research Triangle Park). The most populous municipality is Charlotte, which is the second-largest banking center in...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$161,798 to $230,435

Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019