Head of Regulatory Affairs Italy

Foster City
See job description.
October 22 2020
Other, Other
Position Type
Full Time
Organization Type
Job Type

Head of Regulatory Affairs Italy
Italy - Milan

Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

HEAD of Regulatory Affairs Italy

Responsible for working with local Regulatory Authorities and other stakeholders to ensure that the company complies with country applicable legislations and regulations pertaining to our portfolio (at all stages of the product's life cycle) to ensure that Gilead medicinal products can be developed authorized maintained on the market.

Essential Duties and Responsibilities

Interaction with Local Health Authorities (AIFA mainly)

Leads interactions and communication with AIFA and acts as the main point of contact.

This includes (not exhaustive):
  • Works proactively to build and maintain contacts with relevant local AIFA personnel.
  • Leads interactions with other departments/functions for response to local HAs.
  • Leads all regulatory submissions
  • Management of inspections.
  • Quality defects / falsified or counterfeit products / batch recall management.
  • Out of stock situation management.
  • Management of, or support for incidents involving regulatory matters (as required).
  • Dear Healthcare Provider Communications and Risk Minimization Measures submissions and follow-up until approval.
  • National Scientific Advice and pre-submission meeting preparation and follow-up.

Regulatory Submissions

Ensure that all regulatory submissions to local HAs are done in line with local HA expectations, Gilead SOPs and business. Main types of submissions are (not-exhaustive):
  • Clinical trials applications, Compassionate Use & Early Access Programs
  • Marketing Authorization (MA) application and related variation and maintenance activities.
  • Dear Health Care Professional communication and Risk Minimization Activities materials.
  • Promotional materials.

Local Statutory Responsibilities and Liabilities

Ensure that Gilead fulfills all requirements linked to the Marketing Authorization/ local license as Marketing Authorization Holder or as local representative of the Marketing Authorization Holder.
  • Act as the local Gilead representative as required by national law.

Compliance with the Relevant Laws and Regulations that relate to the Core Activities of Regulatory Affairs in Gilead

Ensure compliance with local law and regulation and consistency with global procedural documents.
  • Lead the creation, maintenance, training, evaluation and tracking of all local regulatory owned procedural documents including policies, SOPs, manuals and working instructions that are needed locally to fulfill regulatory obligations including but not limited to those in the scope of GMP/GDP, GCP and the Promotion Charter.
  • Manage Local Regulatory Audits and Regulatory Compliance audit within affiliate and assure that the General Manager and other departments are aware and support the process.
  • Set up and Maintain quality management system, as required and set up internal and 3PL audits management as appropriate. Ensure the establishment of Quality Agreement where required including with manufacturing/Distribution sites including 3PL.
  • Promotional material review and approval, submission to HA if applicable.
  • Ensure compliant labeling for Gilead medicinal products in the country (SmPC, PIL, packaging) and manage timely updates.

Input into Development
  • Provide input to the global regulatory product strategy, upon request. Get the knowledge on HA expertise, expectations and requirements, National scientific advice relevance and requirements. Manage negotiations with local HAs with regards to products under development

Regulatory Intelligence
  • Closely monitor and report all external relevant changes to concerned stakeholders within the company at local and global level. 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.
  • Maintains up to date knowledge of highly complex regulatory requirements, contributes to preparation of new local regulatory guidance when applicable, comments on draft regulatory guidance and communicates changes in regulatory information to Int RA.
  • Participates in industry trade groups and regulatory affairs professional societies.

Management and Leadership
  • Provide the RA Vision and Direction at the country level in line with global RA and the local Affiliate
  • Serves as a core member of the country leadership team as the representative of R&D.
  • Leads the country regulatory team and serves as a core member on the International Regulatory Heads' fora.
  • Sets clear goals and objectives in line with the global RA strategy.
  • Leads and / or represent RA within cross-functional and/or cross-regional regulatory sub-teams.
  • Plan, monitor, allocate and optimize resources and budget with regards to portfolio evolution as well as regulatory changes.
  • Develop local RA team with clear succession plans for critical roles.

Key Differentiating Responsibilities / Contributions
  • Ensure optimum execution of Int RA strategies, establishes and maintains strong relationships with all functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc)
  • Decision Making: Makes important decisions that impact the department and ensure appropriate communication.
  • Takes a leadership role in conducting risk assessments on major local regulatory issues.
  • Plays an active role in industry organizations building recognition as a thought leader, as required locally if appropriate
  • Initiates or contributes to local and / or global process improvements which have a significant impact on Gilead

Professional Experience / Key Skills
  • Typically requires a Pharmacist Degree and a Masters in Pharmaceutical Sciences or equivalent discipline and extensive relevant experience in regulatory affairs. An advanced degree is desirable.
  • Extensive experience in and understanding of role of RA and regulatory requirements in Pharmaceutical / Biotech Industry
  • Very good influencing and negotiating skills. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
  • Demonstrates strong leadership skills with a sphere of influence externally, cross-functionally and within the RA function and in the affiliate
  • Previous people management experience if needed and direct experience working with Regulatory Authorities essential
  • Excellent decision-making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated
  • Excellent verbal, written, organization skills and interpersonal communication skills.

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.

To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Italy---Milan/Head-of-Regulatory-Affairs-Italy_R0015862-1

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