Ein Angebot von

Regulatory Affairs Manager (m/w/d)

80331 München
20.12.2018

Daten dieser Anzeige

Job-ID: 009328334
Regulatory Affairs Manager (m/w/d)

über experteer GmbH

Germany

https://www.experteer.de/career/lp/signup_vertical_full_job/1_2018?job_id=15328080&affiliate=jobware_hh_feed_basic&utm_medium=metasearch&utm_source=jobware&utm_content=job&utm_campaign=jobwarehhfeedheadhunterbasic

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 Affiliate's 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 teamsknowledge e.g. on: HA expectations and requirements as well as nationalscientific 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 o 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.

Regulatory Affairs Manager (m/w/d) Standort: Greater Munich area Gehalt: vertraulich 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 drugs for 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 is operating 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 Your tasks 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 Affiliate's 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 teamsknowledge e.g. on: HA expectations and requirements as well as nationalscientific 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 o 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. Your qualifications 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 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. Jetzt bewerben

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Forschung & Entwicklung

Sonstige Branchen

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

80331 München