Head of Regulatory Affairs
Company: Regulatory Affairs Professionals Society
Posted on: April 10, 2021
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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
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.
- Ensure regulatory compliance policies and risk factors are
understood and administered company-wide by the management
- Assess and manage regulatory and compliance risk
- Advise on regulatory strategies for market expansion.
- Directs the development and execution of sound regulatory
strategies for the development and registration of assets under
- 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
- Manage through oversight, contractors/consultants, CROs and
budget of the Regulatory, Pharmacovigilance/Drug Safety and Quality
- 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"
- Manages and guides staff to optimal performance.
- Works closely with Training Function on developing training
programs in relevant areas to ensure compliance with applicable
- 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
- 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
- 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
- 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
- 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
- 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
- Registered member of regulatory affairs or other related
- Experience in overseeing audits and regulatory
- Broad knowledge of US and European regulatory systems.
- Demonstrated ability to handle competing priorities
- Sound performer in interacting with and influencing regulatory
- Clear and logical thinker with the ability to recognize
patterns and develop innovative, entrepreneurial solutions. SKILLS
- 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
- 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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