Global Regulatory Affairs CMC Lead CAR-T Princeton,US
il y a 3 semaines
Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in 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 CMC Lead CAR-T.
Scope of the job
Provide regulatory scientific Chemistry, Manufacturing, and Control (CMC) CAR-T/cell therapy expertise and leadership to the Regulatory Affairs team and the CMC team, on a global scale and in an effective and compliant manner throughout all phases of development and lifecycle management.
Your role
- Obtain and maintain regulatory approvals for Galapagos' CAR-T/cell therapy products.
- Act as the company representative for drug development CAR-T/cell therapy CMC activities to health authorities and regulatory vendors. Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
- Be the primary Galapagos regulatory CMC contact point for CAR-T/cell therapy drugs developed in collaboration with partner companies.
- Act as point of contact to cross-functional teams on regulatory CMC project issues. Ensure project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success and timelines, exercising sound judgement, and communicating in a professional and timely manner.
- Develop and provide regulatory CMC strategy and tactics for effective compound development to the regulatory affairs and CMC teams. Provide strategic and tactical input in regulatory CMC dossiers (e.g. Quality IMPDs, Module 3 and QoS documents for INDs or marketing authorisations, CMC lifecycle management dossiers).
- Prepare and follow-up on formal CMC scientific and regulatory interactions with global regulatory agencies (including management of regulatory deliverables and commitments).
- Keep abreast of developments in CAR-T/cell-therapy CMC regulatory affairs and drug development strategies and requirements; inform and advise the internal organization.
- Ensure adequate tracking, archiving and records clean-out activities for assigned projects.
- Ensure full compliance with all applicable regulatory and legal requirements and ensure alignment to company processes.
- Adhere to existing Galapagos Policies and Procedures and timely completion of relevant training.
- Evaluate change proposals and provide assessment of global regulatory impacts and plans global amendments.
Who are you?
- Bachelor's Degree in a scientific discipline is required; advanced degree is preferred.
- Minimum 10-15 years of relevant pharmaceutical/biotech experience including at least 5 years of Global Regulatory CMC experience, preferably with CAR-T/cell therapy or viral vaccine medicinal product development.
- 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.
- 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 related to CMC submissions and product development meetings; international experience preferred.
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 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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