Global Regulatory Affairs Lead CAR-T Princeton,US
il y a 2 semaines
Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.
We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.
We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The 'make-it-happener'.
We are looking for a Global Regulatory Affairs Lead CAR-T.
Scope of the job
Provide regulatory scientific expertise as a standing member of assigned global CAR-T/cell therapy project and clinical development teams.
Deliver and execute the regulatory strategy upon endorsement by the project team, in an effective and compliant manner throughout all phases of development.
Serves as the primary liaison to regulatory agencies and leads submission activities to regulatory agencies.
Act as leader by mentoring, coaching, and developing people to fulfill their potential while also delivering business objectives.
Your role
Obtain and maintain regulatory approvals for Galapagos' CAR-T/cell therapy products.
Act as the company representative for drug development and maintenance activities to health authorities and regulatory vendors. Manage vendors and/or clinical research organizations (CROs) performing regulatory activities on behalf of the company.
Be the primary Galapagos regulatory contact point for cell-therapy drugs developed in collaboration with partner companies.
Ensure full compliance with all applicable regulatory and legal requirements and ensure alignment in the company processes.
Act as point of contact to cross-functional teams on regulatory project issues. Ensure project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success and timelines, exercising sound judgment, and communicating in a professional and timely manner.
Develop and provide regulatory strategy and tactics for effective compound development to the assigned development project teams, and where relevant, clinical development teams.
Serve as the primary liaison with FDA and other regulatory agencies throughout development of projects, including regulatory agency meetings and teleconferences. Represent Regulatory Affairs on the cross-functional Project Team. Advise on, implement, and execute the regulatory strategy endorsed by the Project Team.
Lead the preparation, compilation, and ensure regulatory content quality check of scientific regulatory dossiers and briefing packages (e.g., IND, MAA, scientific advice, pediatric investigation plan, orphan drug designation). Establish a close working relationship with and make optimal use of the other regulatory affairs roles.
Keep abreast of developments in regulatory affairs and drug development strategies and requirements; inform and advise the internal organization, providing interpretive guidance and ensuring applicable implementation into development planning and execution. Provide guidance to the assigned regulatory affairs liaison on the expected regulatory intelligence input.
Ensure adequate tracking, archiving, and records clean-out activities for assigned projects.
Adhere to existing Galapagos Policies and Procedures and timely completion of relevant training.
Who are you?
At minimum 10-15 years of Global Regulatory Affairs experience, strongly preferred in CAR-T/cell therapy medicinal product development in a broad range of clinical/regulatory affairs projects in the pharmaceutical/biotech industry and/or with regulatory authorities.
A profound and demonstrated knowledge of the international regulatory affairs environment with a sound understanding of the pharmaceutical/biotech business environment.
Proven understanding and ability to provide regulatory strategic guidance to drug development, registration, and post-market product teams.
Successful track record of providing robust regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
Must have in-depth experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs).
Ability to effectively liaise with Regulatory Agencies, having served as lead in successful Agency interactions including formal meetings.
What's in it for you?
At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.
We offer a competitive compensation package and a supportive work environment with a strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.
Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.
We are Galapagos: together we can make it happen…
Base compensation for this position ranges from $142,450 to $264,550. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills, and geographic location. The company reserves the right to modify base salary ranges at any time.
In addition, this position is eligible for participation in both Galapagos' performance bonus plan and long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.
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