Regulatory Affairs Manager/ GDP Responsible Person - Romania

Regulatory Affairs Manager/ GDP Responsible Person - Romania
Poland - Warsaw

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

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Company

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.

The Position

Regulatory Affairs Manager/ GDP Responsible person shall serve as a core member of the affiliate Regulatory Team. He/she will interact with local Regulatory Authorities and other stakeholders to ensure that the company complies with country applicable legislations and regulations pertaining to Gilead portfolio and will be responsible for obtaining and maintaining of the Wholesale Distribution License.

Key duties:

• Responsible for obtaining and maintaining WDA and become the primary point of contact to the Health Authorities for the WDA and Quality
• Responsible for establishing and maintenance of the Quality Management System (SOPs, Quality Agreements with supplier(s) and with 3PL)
• Manages change control, quality managerial reviews, risk analysis
• Collaborates with 3PL
• Establishes meaningful GDP KPIs for the 3PL, monitors performance
• Manages recalls, quality claims, returns, suspected counterfeit products
• On behalf of the Marketing Authorization Holder implements local requirement resulting from the Falsified Products Directive
• Plans, trains and maintains training records of the concerned personnel at the affiliate and 3PL level
• Hosts GDP audits and inspections
• Manages out of stock situations, notifies health authorities as required
• Ensures self-inspections and audit or co-audit all concerned vendors
• Monitors local legislation and notify concerned internal stakeholders as applicable
• Collaborates with the Marketing Authorization Holder and/or Manufacturer on quality matters
• Acts as subject matter expert for Regulatory and GDP matters to support Regulatory Head
• Contributes to obtaining regulatory approvals for Compassionate Use/Early Access Programs, including import permits, translation exemptions, etc.
• Coordinates Risk Minimizations Measures and Dear Health Care Communications (submission, follow-up, approval, archiving)
• Ensures compliant labeling for Gilead medicinal products (SmPC, PIL, Packaging, blue box, etc.) including product mockups
• Ensures timely dissemination of the approved product annexes
• Collaborates with Regulatory service provider, as required,
• Monitors local legislation and notify concerned internal stakeholders as applicable

Knowledge, Experience and Skills:

• A degree in pharmaceutical/medical education
• Having 4 to 6 years of relevant experience in regulatory affairs
• At least 1 year of practical experience in the handling, storage and distribution of medicinal products or in transactional activities performed in connection with the purchase or sale of medicinal products
• Membership of the Romanian College of Pharmacists
• Knowledge related to the distribution of medicines, including in relation to the provisions of the Health Law, the Guidelines on Good Distribution Practices and any other laws applicable to the distribution activities
• Proficient in application of QA principles, concepts, industry practices, and standards.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Proven analytical and conceptual skills.
• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates working knowledge with good proficiency in Microsoft Office applications.
• Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.

Behaviours

• Resilient 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
• Organised with systematic approach to prioritisation
• Process orientated to achieve the business objective

Gilead Core Values

• Integrity (always doing the right thing),
• Teamwork (collaborating in good faith),
• Excellence (working at a high level of commitment and capability)
• Accountability (taking personal responsibility).

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Poland---Warsaw/Regulatory-Affairs-Manager--GDP-Responsible-Person---Romania_R0020386

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