Manager / Senior Manager Regulatory Affairs - Dutch Affiliate
Manager / Senior Manager Regulatory Affairs - Dutch Affiliate
Netherlands - Amsterdam
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
Manager / Senior Manager Regulatory Affairs - Dutch Affiliate
Job Title: (Senior) Manager Regulatory Affairs
Department: Regulatory Affairs Department, Gilead Sciences Netherlands B.V.
Location: Amsterdam, The Netherlands
Reports to: Reg Head / Director Regulatory Affairs, Gilead Sciences Netherlands B.V.
The Manager Regulatory Affairs will serve as a core member of the Dutch Affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country's applicable legislations and regulations pertaining to our portfolio (at all stages of the product's life cycle) i.e. ensure that Gilead medicinal products can be
- maintained on the market
ESSENTIAL DUTIES AND RESPONSIBILITIES
Core Technical Regulatory Contributions
Interaction with Local Health Authorities (HA)
- Manage interactions and communication with the local HAs and act as the main point of contact for the local HAs for specific topics under their responsibility. This includes (not exhaustive):
- Works proactively with relevant local HA personnel when applicable.
- Co-ordinates responses to local HAs involving input from other departments/functions
- Support the Regulatory Head on National Scientific Advice and pre-submission meeting preparation and follow-up.
- Acts as subject matter expert and/or assists with the management of local HA inspections (as required)
- Management/support of quality defects / falsified or counterfeit products / batch recall management.
- Management/support of product out of stock situations.
- Support for incidents involving Regulatory matters (as required).
- Dear Healthcare Provider Communications submissions and follow-up until approval.
- Risk Minimization Measures submissions and follow-up until approval.
Manage Regulatory submissions to local HAs, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.
Main types of submissions are (not exhaustive):
- Clinical trials applications, amendments and other clinical trials submissions.
- Compassionate Use & Early Access applications.
- Marketing Authorization (MA) applications.
- Variations and other MA maintenance applications.
- Import permits.
- Risk Minimization Activities materials.
- Dear Health Care Professional communication.
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.
Responsibilities Responsible Person (RP)
Law reference EU GDP Guidelines, Dutch Medicines Act
Training/Education required As defined in the Dutch Medicines Act
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 GxP for assigned product(s) or projects.
- 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.
- Integration of transplant products / gene therapy portfolio quality requirements into the Gilead Quality Management Systems including quality agreements, distribution processes (export/import licenses) and understanding if there are data protection law implications. Support of local site qualification if needed.
- Support maintenance of GDP license in the country, as required, and have the capability to set up internal and 3PL audits as appropriate.
- Support establishment and maintenance of an operating license for transplant/ gene therapeutic medicinal drug products.
- Support establishment of Quality Agreement where required with 3PL.
- Promotional material review and approval, submission to HA if applicable for assigned product(s).
- Ensure compliant labeling for Gilead medicinal products (SmPC, PIL, packaging) and manage timely updates for assigned product(s).
Input into Development
- Provide input to Reg Head to support Regulatory product strategy, upon request.
- Share with Global Regulatory Affairs organization knowledge on:
- HA expertise, expectations and requirements
- National scientific advice relevance and requirements
- Regulatory Authority contact profiling
- Serve as a core member of the Local Regulatory team to help manage negotiations with local HAs with regards to development products and questions on clinical trial applications.
Contribute in the monitoring and report of external relevant changes to concerned stakeholders within the company at local and global level if applicable. 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.
Contribute in the monitoring of competitor Regulatory information such as approvals, changes in label and other relevant local details. If applicable, Regulatory Affairs (RA) contributes to relevant local guidelines and regulations' development that impact Gilead, identifying trends and changes that may impact on the company.
Manages potential challenges in registration and changes in health care policies that could impact Gilead and provide key input into strategies to optimize the outcome.
- Has the capability to maintain up to date knowledge of 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 the global organization.
- Participates in industry trade groups and Regulatory Affairs professional societies as agreed locally with the Reg Head.
Management and Leadership
Serve as a core member of the Local Regulatory team for the RA organization at the country level in line with global RA, the Regulatory Head and the local Affiliate Visions.
- Serves as a core member of the country brand/launch team or international working group as the representative of Regulatory affiliate.
- When applicable can contribute on the International Regulatory Heads' fora.
- Execute clear goals and objectives in line with the International RA strategy and the local Business and Regulatory Heads Vision.
- Actively participates in internal and external working groups.
- Represent RA within cross-functional and/or cross-regional Regulatory sub-teams.
- Plan, monitor, allocate and optimize management of activities with regards to portfolio evolution as well as Regulatory changes.
- Proactively manage training and development plan for them self and reports (as applicable).
- Coach and train junior Regulatory staff on Regulatory and GDP activities and manage that their activities are performed in compliance with applicable procedures.
- Be capable of taking over the role of the Reg Head for The Netherlands in her/his absence
The responsibilities of the Responsible Person follow the current EU GDP Guidelines (European Commission Guidelines on Good Distribution Practice of medicinal products for human use) and include:
- ensuring that a quality management system is implemented and maintained;
- focusing on the management of authorized activities and the accuracy and quality of records;
- ensuring that initial and continuous training is implemented and maintained;
- coordinating and promptly performing any recall operations for medicinal products;
- ensuring that relevant customer complaints are dealt with effectively;
- ensuring that suppliers and customers are approved;
- approving any subcontracted activities which may impact on GDP;
- ensuring that self-inspections are performed at appropriate regular intervals following a prearranged scheme and necessary corrective measures are put in place;
- keeping appropriate records of any delegated duties;
- deciding on the final disposition of returned, rejected, recalled or falsified products;
- approving any returns to saleable stock;
- ensuring that any additional requirements imposed on certain products by national law are adhered to.
KEY DIFFERENTIATING RESPONSIBILITIES / CONTRIBUTIONS
- Ensure responsibilities of Applicant and/or License Holder defined in legislation or Regulatory for assigned product(s) or projects
- Optimum execution of corporate registration strategies and plans with different functional areas in the affiliate
- Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with the Global Regulatory organization in order to ensure the success of local and international business results from the Regulatory point of view
- Takes a leadership role in conducting risk assessments on specific local Regulatory issues.
- Serve as a core Regulatory member in updating and preparing the company for major changes in Regulatory legislation in the country for assigned product(s) or projects.
- Decision Making: support the Reg Head on important decisions that impact the department and assist with appropriate communication
- Plays an active role in industry organizations on specific working group, building recognition as a thought leader, as required locally by the Reg Head.
- Actively contributes to local and / or global process improvements which have a significant impact on Gilead.
- Represents Regulatory function at internal meetings relevant to assigned product(s) or projects.
- Effectively manages junior Regulatory staff in being trained and performing activities in compliance with applicable procedures.
PROFESSIONAL EXPERIENCE / KEY SKILLS
- Typically requires a Masters in Pharmaceutical Sciences or equivalent discipline and minimum of 8 to 10 years of relevant experience in Regulatory Affairs.
- Strong experience in understanding the role of RA and Regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and current trends in a local affiliate.
- Good influencing and negotiating skills. Must be capable of developing and implementing Regulatory initiatives and managing negotiations with Regulatory Authorities.
- Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the Regulatory organization and the affiliate.
- Experience working with Regulatory Authorities is essential.
- Capable in making well-balanced decisions.
- Flexible in setting priorities
- Excellent verbal, written, organization skills and interpersonal communication skills required.
- Excellent Dutch and English language required.
- Should have appropriate competence and experience as well as knowledge of and training in current GDP (Good Distribution Practice).
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:
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