Asuntos Regulatorios Sr. Manager
hace 6 meses
Description
We are looking for a unique individual who is passionate about advancing therapeutics and with creative problem-solving skills to seamlessly meet the business needs while maintaining regulatory compliance.
This is an exciting opportunity for an experienced regulatory professional to join the Regulatory Affairs team built on a strong sense of teamwork and excellence. This position is based in Mexico City reporting to the Sr Director of Regulatory Affairs. The role involves close cross-functional collaboration with a diverse number of stakeholders both internally and externally.
Define, develop and execute regulatory strategies to maximize regulatory success towards achievement of the program objectives, Provide strategic and tactical advice to achieve timely and efficient regulatory submissions NDA and life cycle maintenance, while ensuring compliance with applicable regulatory requirements, Engage with the broader Regulatory community within Gilead Sciences Contribute to cross-functional initiatives and represent the regulatory function at the International project team meetingsEssential Duties and Responsibilities include the following:
Collaborating cross-functionally to ensure the development and execution of robust regulatory strategies whilst ensuring regulatory compliance Ensure project team colleagues, line management, and key stakeholders are appraised of developments that may impact regulatory success whilst exercising sound judgement and communicating in a timely manner Responsible for anticipating and quantifying risks and proposing solutions including the probability of success Accountable for regulatory submissions and approvals, in collaboration with internal and external stakeholders Participate in trade associations interactions/meetings Accountable for establishing strong working relationships with the regulatory central team, other functions as required Participate in or lead departmental and cross-functional taskforces and initiatives Actively monitor and anticipate trends that impact the regulatory environment and adapt regulatory strategies in a timely manner Facilitate manufacturing sites registration in line with national requirements Point contact at the cross functional and International project team meetings Review and approve promotional materials in accordance with national legislation and Codes of Practice and company policies and procedures. Establishes and supports maintenance of GDP, Importer’s and Wholesaler’s license and Quality Agreements related to cell/gene therapy product(s). Responsible for demonstrating Gilead leadership commitmentsEducation & Experience:
BSc, MSc or PhD in a scientific discipline with extensive experience in the pharmaceutical/biotechnology industry in Mexico Extensive knowledge of regulatory landscape in Mexico. Experience in developing and implementing complex regulatory strategies. Experience in critically reviewing complex technical documents and influencing colleagues across functions towards successful implementation of regulatory strategies.Skills & Behaviors
Self-motivator, enthusiastic, tenacious and energizing. Proactive and open to share, advise and educate colleagues across the organization. Agile in an evolving environment. Resilient with the ability to influence and deliver in an ambiguous environment. Ability to engage stakeholders and manage multiple stakeholders to achieve the objective. Ability to transition from strategic to operational in order to deliver objectives according to established plans and business needs. Excellent verbal & written English, negotiation, influence and interpersonal communication skills Detailed oriented. A good team player.Gilead Core Values
Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility)Leadership commitments
I AM BOLD in aspiration and AGILE in execution. I CARE and make time for people. I LISTEN, speak openly and explain the "why." I TRUST others and myself to make sound decisions. I OWN the impact of my words and actions.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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