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Associate Director Regulatory Affairs

Munich, Germany | Gilead Sciences

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    Regulatory Affairs
  • Experience:
    7-10 years
Job Description:
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The Position:

The Associate Director Regulatory Affairs (m/f/d) will ensure that Gilead 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. He/she will make sure that the medicinal products in their responsibility can be developed, authorized and maintained on the market. He/she will also serve as a core member or may lead cross functional project teams locally and regionally.

Specific Job Requirements:

Supports 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)

Ensures compliant labeling for Gilead 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

Provides 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

Manages interactions, negotiations and communication with local HAs and acts as the main point of contact for the local HAs for specific topics/products under their responsibility

Helps 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

Initiates local process improvements and contributes to local and/or global process improvements which have a significant impact for RA and other departments, assesses proposed changes to local procedural documents and impact on existing processes

Supports 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

Has the knowledge and experience to actas a local Gilead representative as required by local law e.g. RP QA, “Informationsbeauftragter”, etc

Acts 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

Serves 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 contributes to guideline and regulation development

Represents Regulatory Function at internal and external meetings or working parties building recognition as a thought leader

Knowledge, Experience & Skills

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

Education and Experience 

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

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