- Stellenanzeige Nr. 419335 | letzte Aktualisierung: 22.02.2019 / 12:06 Uhr

Regulatory Affairs Manager (m/w/d) HIV/AIDS #25068
Zum Unternehmen

Optares GmbH & Co. KG
Our Client is a leading and worldwide operating biopharmaceutical enterprise whose German subsidiary is based in the greater Munich area in Germany. Be responsible for the market leading portfolio of drugsfor a company that has a great ethic approach and will foster your personal development with strong impulses. At the beginning you will first of all get to know your portfolio, your team and cross functional partners, the next step isoperating your portfolio in regulatory affairs with all needed actions such as Clinical Trial applications, amendments and other clinical trials submissions.

We are searching as soon as possible for a dedicated and experienced

Regulatory Affairs Manager (m/w/d) HIV/AIDS
Standort: Greater Munich area
Kennziffer: 25068

Zur Position
Regulatory Affairs Manager (m/w/d) HIV/AIDS #25068
 [Referenznr. 25068]
Manage regulatory submissions to local Health Authorities (HA), in line with local HA expectations, SOPs and business objectives for assigned product(s) or projects
Clinical trials applications, amendments and other clinical trials submissions
Compassionate Use & Early Access applications
Marketing Authorisation (MA) applications
Variations and other MA maintenance applications
Risk Minimization Activities materials
Coordinate and manage all regulatory activities for assigned medicinal products as translation of product information and implementation of product information into relevant national texts
Manage interactions and communication with the local HAs and act as the main point of contact for the local HAs for specific topics
Act as a core member of the Affiliates Regulatory Team to ensure compliance with local law and regulations and consistency with global procedural documents
Contribute to the creation, maintenance and training of local regulatory owned procedural documents including policies, SOPs, manuals and working instructions that are needed locally to fulfill regulatory obligations.
Support Regulatory audits within the Affiliate and interact with other departments and support the process as needed.
Perform review and approval of promotional and non-promotional materials for assigned area of responsibility.
Ensure compliant labeling for medicinal products (SmPC, PIL, packaging) and manage timely updates for assigned product(s)
Provide input for regulatory development projects.
Support regulatory product strategy, upon request.
Share with International Regulatory Affairs (Int RA)/development teams knowledge e.g. on: HA expectations and requirements as well as national scientific advice.
Act as a core member of the local Regulatory team to support negotiations with local HAs with regards to development products e.g. questions on clinical trial applications
Contribute in the monitoring and report of external relevant changes to concerned stakeholders within the company at local and global level if applicable. That applies for local requirements to be explained at the local and International level but also for changes or new information at International level affecting Affiliates.
Contribute in the monitoring of competitor regulatory information such as approvals, changes in label and other relevant local details.
Act as a core member of the local Regulatory team for the RA organization at the country level in line with global RA, the Regulatory Head and the local Affiliate Visions.
Act as a core member of the country brand/launch team or international working group as the representative of regulatory Affiliate.
Execute clear goals and objectives in line with the International RA strategy and the local Business.
Actively participate in local and international working groups.
Represent RA within cross-functional and/or cross-regional regulatory subteams.
University degree in natural science with a minimum of 3-4 years relevant experience in Regulatory Affairs
Strong experience in understanding the role of regulatory affairs and regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and national requirements
Capability of developing and implementing regulatory initiatives and managing negotiations with regulatory authorities
Teamplayer and strong cross-functionall ability
Strong analytical skills and decision making to interpret regulatory data
Excellent organization skills to carry out diverse activities in a swift changing and demanding environment
Ability to work in a teamwork environment
Excellent communication skills verbal and written (German and English) with well-developed interpersonal skills
Wir bieten
Seit 2003 vermittelt Optares Medical erfolgreich Fach- und Führungskräfte an Unternehmen der pharmazeutischen, biotechnologischen und medizintechnischen Industrie. Dabei profitieren Sie als Kandidat durch unsere langjährige Branchenexpertise und unser weit reichendes Netzwerk zu den jeweiligen Entscheidungsträgern. Wir ermöglichen Ihnen somit den Zugang zu passgenauen Positionen inklusive echten Herausforderungen und entsprechenden Weiterentwicklungsmöglichkeiten.

Die professionelle, diskrete und transparente Betreuung unserer Kandidaten während des gesamten Bewerbungsprozesses steht dabei für uns im Mittelpunkt.
Gewünschte Qualifikationen

University degree in natural science with a minimum of 3-4 years relevant experience in Regulatory Affairs
Forschung & Entwicklung
Einsatzort (Freitext)
Greater Munich area
Einsatzort (Region)
(Deutschland) Bayern
Kontakt für Bewerber

Optares GmbH & Co. KG
Herr Tilman Grumbd
Heiligengeist Höfe 8
26121 Oldenburg
Tel.: 0441 2187934
Fax.: 0441 2187916



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