Regulatory Affairs Manager
Regulatory Affairs Manager
Israel - Tel Aviv
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
Regulatory Affairs Manager, Oncology
Reporting to the Director Regulatory Affairs Israel, you will be responsible for working on regulatory applications and maintenance - acting as the appointed pharmacist for Gilead products.
Serve as a core member of the affiliate Regulatory Team interacting 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).
Working with cross-functional teams you will be an excellent communicator and will be responsible for ensuring that all projects have the appropriate regulatory and quality input and guidance. A proactive and positive mind-set and can-do attitude is essential.
You will have a solid knowledge of local regulatory affairs and quality and have previously worked within the Pharmaceutical industry.
Essential Duties and Responsibilities
Interaction with Local Health Authorities (HA)
Being an appointed pharmacist, you will manage interactions and communication with the MOH and act as the main point of contact for the MOH for specific products under your responsibility. This includes (not exhaustive):
- Co-ordinates responses to the MOH involving input from other departments/functions
- Acts as subject matter expert and/or assists with the management of local HA inspections (as required)
Manage regulatory submissions to the MOH, in line with the MOH standards and submission guidelines, Gilead SOPs and business objectives for assigned product(s) or projects.
Takes a leadership role in conducting risk assessments on specific local regulatory issues.
Main types of submissions are (not-exhaustive):
- Marketing Authorisation (MA) applications.
- Variations and other MA maintenance applications.
- Import permits.
- Risk Minimization Activities materials.
- Dear Health Care Professional communication.
- Labelling revision and updates
- Review of promotional materials
Compliance with the Relevant Laws and Regulations that Relate to the Core Activities of Regulatory Affairs in Gilead
- Serve as a core member of the Affiliate Regulatory Team to ensure compliance with local law and regulation and consistency with global procedural documents.
- Lead or assist the Reg. Head in leading the creation, maintenance, training, evaluation and tracking of 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 Regulatory, GMP/GDP, and PV.
- Serve as a core member of the Affiliate Regulatory team to manage Regulatory Compliance audits within the affiliate and interact with other departments and support the process as needed.
- Assist the regulatory head in Promotional material review and approval.
- Ensure compliant labeling for Gilead medicinal products (SmPC, PIL, packaging and artworks) and manage timely updates for assigned product(s).
- Act as local Coordinator for Gilead systems if required by Reg. Head.
Key Differentiating Responsibilities / Contributions
- Serves as a core member of the country brand/launch team or international working group as the representative of regulatory affiliate
- Execute clear goals and objectives in line with the International RA strategy and the local Business and Regulatory Heads Vision
- Decision Making: Support the Reg head on important decisions that impact the department and assist with appropriate communication
- Actively contributes to local and / or global process improvements which have a significant impact on Gilead.
- Formulate local regulatory strategy in collaboration with stakeholders
- Execution of strategy and plans according to a pre-determined action.
Professional Experience / Key Skills
- Licensed pharmacist in Israel, previously with an appointed pharmacist and role (previously approved by the MOH to be an appointed pharmacist)
- Proven, relevant experience in regulatory affairs
- Experience the oncology therapeutic area.
- Fluent in both Hebrew and English (written and spoken), excellent verbal, written, organization skills and interpersonal communication skills required.
- Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.
- Previous people or project management experience is beneficial and experience working with Regulatory Authorities essential
- Well organized and independent
- Team player
- Change and Learning agile
Gilead Core Values
- Integrity - doing what\'s right
- Teamwork - working together
- Excellence - being your best
- Accountability - taking personal responsibility
- Inclusion - encouraging Diversity
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/Israel---Tel-Aviv/Regulatory-Affairs-Manager_R0020929-2
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