Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

CROMSOURCE

Germany

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting an Associate Director Regulatory Affairs to strengthen the team of one of our clients.

Scope of the role

  • Ensure that the company complies with country's applicable legislations and regulations linked to the Marketing Authorization (MA)/local license as MA Holder or as local legal representative of the MA Holder;
  • Make sure that the medicinal products in their responsibility can be developed, authorized and maintained on the market;
  • Serve as a core member or may lead cross functional project teams locally and regionally.

Main Job Tasks and Responsibilities

  • Support regulatory submissions to local Health Authority (HA), including variations, risk minimization measures, Dear Healthcare Provider Communications, compassionate use, early access, license renewals as well as clinical trial applications and amendments, which may require extensive interaction with departments outside of Regulatory Affairs (RA);
  • Ensure compliant labelling for medicinal products and manage translation reviews and timely updates for assigned product(s);
  • Lead or support country/national scientific advice and/or pre-submission meeting preparation and follow-up;
  • Provide strategic regulatory advice as appropriate including input into clinical development programmes;
  • May manage a team of Regulatory professionals or lead the country Regulatory activities for specific therapeutic areas;
  • Manage interactions, negotiations and communication with local HAs and act as the main point of contact for the local HAs for specific topics/products under their responsibility;
  • Help ensure compliance with local law and regulation and consistency with global procedural documents including acting as a subject matter expert or the management of audits and inspections within the affiliate;
  • Initiate local process improvements and contribute to local and/or global process improvements which have a significant impact for RA and other departments, assess proposed changes to local procedural documents and impact on existing processes;
  • Support maintenance of GDP license and Quality Agreements, as well as an operating license for transplant/gene therapeutic medicinal drug products in the country, as required;
  • Support or management of quality defects, falsified or counterfeit products, batch recalls and stock out as required;
  • Responsible for promotional material review and approval;
  • Have the knowledge and experience to act as the company's local representative as required by local law e.g. RP QA, "Informationsbeauftragter", etc.;
  • Act as a consultant to local Affiliate, regional, Intl or Global RA teams on Affiliate matters;
  • May take a leadership role in conducting risk assessments on specific local regulatory issues;
  • Serve as a core Regulatory member in updating and preparing the Company for major changes in regulatory legislation and competitor information in the country for assigned product(s) or projects and contribute to guideline and regulation development;
  • Represent Regulatory Function at internal and external meetings or working parties building recognition as a thought leader.

Education, Experience and Skills

  • Minimum 7 years of experience in RA or other relevant industry experience with advanced scientific degree;
  • Excellent knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical/Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local affiliate;
  • Must be capable of developing and implementing regulatory strategy and managing complex negotiations;
  • Knowledge in quality assurance, promotional and non-promotional review as well as pharmacovigilance and market access is advantageous;
  • Experience in working and leading cross-functional project teams;
  • Previous people management experience is desirable;
  • Excellent working knowledge regarding country/national and regional HAs (people, system, processes and requirements) essential;
  • Leadership skills showing the ability to influence externally, cross-functionally and within regulatory function;
  • Must have the ability to work and negotiate with a HA;
  • Must be capable of leading project teams;
  • Good decision making and prioritization skills are important;
  • Excellent verbal and written English language skills, organization skills and interpersonal communication skills required.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Germany     Clinical Research     Manager and Executive     Regulatory Affairs     CROMSOURCE    

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies