What’s a Regulatory Affairs Manager?

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 law.
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 Drug Information
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.

Team Roles
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.

Qualifications:

University graduate in  pharmacy, life-science, medicine or chemistry with approximately 4-5 years relevant pharmaceutical business experience or master degree in  regulatory affairs. 
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 procedural problems.
Interaction with and influencing of others, both internally and externally, is a key part of the function requiring human-relation skills.
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 the career.