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Gilead

Associate Director Regulatory Affairs (m/w/d)

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Associate Director Regulatory Affairs (m/f/d)

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 act  as 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

Behaviours

  • Resilient and acumen profile with the ability to deliver in an ambiguous environment
  • Ability to engage and manage multiple stakeholders to achieve the objective
  • Curious with learning agility
  • Operationally excellent
  • Organized with systematic approach to prioritization
  • Process orientated to achieve the business objective

Gilead Commercial competencies

  • Initiative into Action
  • Strategic approach
  • Communications Impact and influence
  • Customer relationship building
  • Customer and market insights
  • Business analytics

Gilead Core Values

  • Integrity (Doing What’s Right),
  • Teamwork (Working Together),
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility).

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

For more information please visit Gilead.com

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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