What’s a Regulatory Affairs
This job title reflects a typical job in the pharmaceutical industry or
registration agency for drugs and medical devices (human and/or veterinarian
use). It covers all administrative activities required to attain official
permission to develop, produce, market and sell health-care products.
Topics: Drug Approval under Regulatory Requirements
Supervise preparation of marketing authorization applications (MAA's) for new pharmaceutical and diagnostical
products. Or – in the agency – coordinate the same activities
in the approval process, eg check of
completeness, informal texts etc. These MAA's
are complex and comprehensive records normally in the written countries
language of the registration agency providing factual information and
expert reports relative to drug quality (pharmaceutical-chemical
information), drug safety (pharmacological-toxicological information) and
drug efficacy (clinical research results) along with proposals for use
(indications, therapeutical applications,
control of side-effects and adverse reactions), and packaging
specifications and samples.
Ensure that these MAA's are correct and
complete and submitted in due time to the national regulatory agency
consistent with the company's strategic goals for marketing or the
agencies policy, manufacturing, and selling. Follow up with regular drug
surveillance reports to maintain or renew existing marketing
authorizations. Inform national regulatory authorities without delay of
reported adverse reactions/side-effects or check the complying with the
As the primary company contact with the national regulatory agencies,
(vice versa) strength in agency negotiations, formation of strategy for
responses to data deficiencies, information and policy monitoring, and
acceleration of the review process are required.
Manage patent and trade-mark registration procedures, and in-licensing
and out-licensing where required, including negotiation of licensing
agreements. In the agency: Responsibility for observance of time schedule
and the licensing documents.
Development of the Pharmaceutical Products (Drug Development)
Supervise preparation, and negotiate with regulatory agencies for approval
of clinical study applications to support clinical development during
phases I - III. Or – in the agency: Check them. Provide input to
the International Regulatory Affairs staff on development of regulatory
requirements and policies within all of the countries in Central and Eastern
Europe. Provide advice and guidance to the
International Clinical Research staff on regulatory aspects of drug
development within this geographic area.
Advice to management
Keep company management
– in the agency - or heads of agency and politicians up to
date on status of specific product registration actions, problems and
solutions. Further, inform management of changing or new
national/international legislation and policies in the broad field of
pharmaceuticals and diagnostics, as well as pertinent scientific and
political inputs and influences. In this context form strong professional
relationships with key-influential political, regulatory and trade
association contacts. Attend external seminars, briefings and conferences.
Promotional Material / Commercial
Approve - or in
the agency - as far as they are part of the review process all local
promotional material prior to use. Supervise formulation/editing of local
language labelling texts, package leaflets, product profiles and other
relevant product information for medical practitioners and pharmacists
specifying indications, effects, side-effects, and interactions with
other drugs. As required, present modified texts to the health
authorities for approval.
Serve as member of the European or global Regulatory Affairs Team, which
coordinates Regulatory Affairs activities worldwide and assigns action
responsibility for multi-country MAA's.
University graduate in pharmacy, life-science,
medicine or chemistry with approximately 4-5 years relevant
pharmaceutical business experience or master degree in regulatory
In-depth knowledge of applicable regulatory affairs laws, regulations and
policies, both national and international.
Ability to innovatively search for solutions to complex technical and
Interaction with and influencing of others, both internally and
externally, is a key part of the function requiring human-relation
Ability and skills to manage groups of Regulatory Affairs Associates.
Fluency in English ( business proficiency).
Knowledge of other languages (German, French, Spanish
etc) and in the future east and central European languages will improve