REGULATORY AFFAIRS AND QUALITY - REMOTE OR HYBRID

REALLY VERSATILE JOB – REMOTELY OR HYBRIDEXPERIENCE IN EU REGULATORY AFFAIRS AND QUALITY ASSURANCE DO YOU WANT: Possibility to work remotely - or hydrid. 37 hours weekly. You can count on work-life balanceA very broad and versatile job, partly RA and partly QA, in a generic medical company with MAATo be part of a small Danish office and with colleagues also in other European Countries as a part of an international Group.

Cooperation with QA and RA colleagues in headquarter and other company affiliatesAs Local Quality Responsible Person ensuring that the marketing of drugs distributed by the company complies with the pharmaceutical and legal regulations in accordance with the company’s specifications and the applicable relevant regulations, processes and standards. As QA responsible Person for the wholesale and Good Distribution Practices (GDP) licenses as required by the applicable regulations governing the production and distribution of pharmaceuticals in Denmark, Sweden and Norway. The QA tasks in Denmark are for the time being managed by an external consultant mostly around 10 hours weekly.

Registration and maintenance of some of the companies productsEnsure correctness and grant “approval” of packaging and promotional materials. Continuously challenge workflows and procedures with regard to improvement of personal /team performance. Keep up-to-date with changes in regulatory legislation and guidelines. YOU WILL GET THE OPPORTUNITY TO HANDLE TASKS AS E. G. : Regulatory Affairs as: Preparation, submission, follow-up and maintenance of marketing authorization applications for assigned products. Preparation of the administrative sections (Module 1). Compilation of dossiers using document and submission management tool. Support RA Managers and Head of RA activities.

Communicate outside the organisation on behalf of the company with National Competent Authorities and Customers; ensure that relevant information is shared internally. Timely and liable maintenance of internal and external databases. Ensure correctness and grant “approval” of packaging and promotional materials. Keep up-to-date with changes in regulatory legislation and guidelines. QA as:

Ensure that the Affiliate complies with all applicable local regulatory requirements;Obtain and maintain up-to-date all pharmaceutical licenses as required by local legislation to ensure business continuityImplement locally corporate procedures in due timeManage the maintenance of local quality systemsManage local (Denmark, Sweden and Norway) product recalls and support global product recallsManage the quality oversight of local distributors (e. g. 3PLs, warehouses, transporters) to ensure compliance with Good Distribution Practice (GDP) in Denmark, Sweden and NorwayManage quality complaints from local marketManage change controlsManage selfinspectionsSupport QA on a global level where neededYOU ARE/HAVEProfessionally :

You have some experience within RA and/or QAWillingness to learnFluently in written and spoken English and one of the Nordic languagesPersonally: Responsible, detail-oriented and coordination skillsTeamoriented and also capable of working independentlyKeen on working in an international environment in a small Danish office located in SlangerupPrefer days and tasks that offers great diversity, spiced with routinesAbout the company: The company is a small company located in North Zealand. It is a company in an international pharmaceutical Group, which over the past 32 years has focused on generic products.

The company owns a number of marketing licenses in most of Europe and distributes products worldwide, either directly or through license agreements with the leading companies within the generic industry. The Danish company handles Preparation, submission, follow-up and maintenance of marketing authorization applications for assigned products marketed in Denmark, Norway and SwedenApplication: External consultant, Hurecon, participate in the recruitment. Please send your application to Margaret Petersen from Hurecon to mail mp@hurecon. dk. You are very welcome to call Margaret on cell 20495451