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Head of Regulatory Affairs

Company: Regulatory Affairs Professionals Society
Location: Atlanta
Posted on: April 10, 2021

Job Description:

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items. European Union Regulatory Affairs, Quality/Risk Management, Submission & Registration, US Regulatory Affairs Required Education: 4 Year Degree
This position can be based at in Atlanta or London. The Head of Regulatory Affairs will provide strategic and tactical direction to the Technical Product Development, QA Compliance, Pharmacovigilance and Regulatory Affairs departments. Accountable for developing and establishing strategies, policies, plans and programs in these areas; managing their implementation; and ensuring standards are established and complied with. Represents the company with the Food and Drug Administration (FDA), European and other regulatory bodies on all matters involving the discovery/development, registration, manufacturing, testing, cGMP compliance, drug safety surveillance, marketing and distribution of products. Assists CEO and COO in the development of corporate strategies and objectives ensuring policies and procedures attain corporate objectives. REQUIREMENTS

  • Ensure regulatory compliance policies and risk factors are understood and administered company-wide by the management team.
  • Assess and manage regulatory and compliance risk opportunities
  • Advise on regulatory strategies for market expansion.
  • Directs the development and execution of sound regulatory strategies for the development and registration of assets under development.
  • Responsible for ensuring regulatory operations, life-cycle maintenance of regulatory dossiers, and periodic submissions in all markets are in resourced and in place.
  • Provide oversight to Quality Assurance (QA) function and work closely with Director, QA to assure all company's activities are compliant with applicable rules and regulations.
  • Responsible, with Director, QA, for maintaining Alimera Sciences Global Quality Management System (QMS) and ensuring compliance with quality standards of manufacturing (cGMP), distribution (GDP), clinical research (GCP), and pharmacovigilance (GVP).
  • Manage through oversight, contractors/consultants, CROs and budget of the Regulatory, Pharmacovigilance/Drug Safety and Quality functions worldwide.
  • Establish and revise policies and standards in Regulatory affairs (RA), Pharmacovigilance and QA, as needed and ensure compliance with standards and policies.
  • Represent the company in interactions with regulatory authorities, develop and implement programs that encourage productive interaction with FDA, European and other regulatory agencies resulting in proactive solutions in life-cycle management, drug discovery and drug development.
  • Evaluates functional strengths, undertakes risk-assessment and identifies development areas focusing on attaining "best in class" performance.
  • Manages and guides staff to optimal performance.
  • Works closely with Training Function on developing training programs in relevant areas to ensure compliance with applicable regulations.
  • Oversight and accountable for Regulatory, Pharmacovigilance and Quality activities in U.S. and Europe to ensure that the company's product remain in compliance with marketing authorisations. SCOPE
    • The scope of the role is Global.
    • Dimensions of the role include Regulatory affairs, Pharmacovigilance and Quality Assurance. RESPONSIBILITIES Regulatory Affairs
      • Provide oversight and support to regulatory affairs for submission of applications of marketing authorizations, variations, supplements, and promotional materials.
      • Manage a team of consultants to deliver successful submission of marketing authorization applications and other regulatory documents.
      • Drive regulatory strategy and registration regulatory roll-out, including MRPs for approved products. Provide proactive feedback to pre-empt regulatory challenges worldwide.
      • Collaborate with clinical team to oversee preparation of submissions of CTAs and documents for ethics committee where appropriate.
      • Assist Pharmacovigilance and Medical functions in the development and roll-out of the risk management plans in Europe and ensure Regulatory resources for review of promotional activities in U.S. for submission to the FDA in accordance with regional specific regulations.
      • Oversight of Pharmacovigilance and Drug Safety.
      • With the Director/Associate Director of Drug Safety, ensure compliance with regulatory and GVP requirements and Alimera internal policies and ensure adequate drug safety surveillance including appropriate and timely reports to Health Authorities Quality and Compliance
        • Provide support to pharmacovigilance and drug safety activities and reporting requirements.
        • Provide oversight and support to the director of QA in ensuring compliance of the Company with regulatory requirements, quality standards, and adherence to GxP requirements. General
          • Training: Prepare training materials for internal training (e.g. for sales and marketing personnel) and conduct training sessions on relevant quality, regulatory and safety issues.
          • Budgets: Management of regulatory, pharmacovigilance and quality budgets. QUALIFICATIONS
            • Advanced degree in life sciences or chemistry required, preferably to a higher-level qualification

            • At least 15 years' experience with increasing levels of responsibility in leadership roles in Regulatory Affairs and/or Quality.

            • Must have outstanding record of accomplishments with regulatory agencies on a global basis. High level of technical and comprehensive knowledge of drug development, Regulatory affairs, Pharmacovigilance, Quality, and compliance required.

            • Thorough knowledge of FDA, European and ICH regulations.

            • Possess excellent planning and organizational skills, time management, communication, decision making and presentation skills.
            • Registered member of regulatory affairs or other related professional bodies
            • Experience in overseeing audits and regulatory inspections.
            • Broad knowledge of US and European regulatory systems.
            • Demonstrated ability to handle competing priorities effectively.
            • Sound performer in interacting with and influencing regulatory authorities.
            • Clear and logical thinker with the ability to recognize patterns and develop innovative, entrepreneurial solutions. SKILLS & COMPETENCIES
              • Flexible approach, the ability to take on new learning and to operate in a wide range of areas, both therapeutically and generally. Able to think creatively and laterally, with the ability to think 'outside the box'. Prepared to 'roll up the sleeves' and get things done.
              • Effective and influential communicator - both one-to-one and in a team environment. Outstanding inter-personal skills coupled with keen analytical acuity.
              • Strong organizational skills - able to plan and prioritize time effectively.
              • Effective networker and team worker - must be able to develop effective working relationships with colleagues and with external partners, in particular regulatory authorities. Comfortable within and working across a matrix organisation and cross-functional teams, including external vendors.
              • Self-motivated, self-reliant, able to work independently. Evident results orientation, with the drive to see things to completion - a real 'can-do' approach.
              • Strong analytical thinking and problem-solving skills - process orientated with good attention to detail. Proven ability to deliver well thought-through and evaluated solutions. Internal Number: 2021 About Alimera Sciences Founded in 2003, Alimera Sciences is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is dedicated to providing eye-care professionals and their patients with innovative, vision improving treatment for diseases affecting the back of the eye, primarily focusing on the retina, because these diseases are not well treated with current therapies and affect millions of people in aging populations.Headquartered in Alpharetta, Georgia, USA, Alimera Sciences employs more than 150 people, around a third of whom are based in Europe. Alimera's European offices are located in the UK, Germany, Ireland and Portugal. On September 26, 2014, The US Food and Drug Administration approved ILUVIEN--(fluocinolone acetonide intravitreal implant) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN-- is an intravitreal implant of fluocinolone acetonide and is the first DME treatment to deliver 36 months of continuous, low-dose corticosteroid with a single injection. Regulatory Affairs Professionals Society (RAPS)
                5635 Fishers Lane, Suite 400
                Rockville, Maryland 20852

Keywords: Regulatory Affairs Professionals Society, Atlanta , Head of Regulatory Affairs, Other , Atlanta, Georgia

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