Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
1. GENERAL INFORMATION
Function: Director, Regulatory CMC Device Leader
2. PURPOSE OF THE FUNCTION
- Lead the Regulatory CMC strategies for Device & Combination Drug Products
- Provide strategic leadership for combination products across development, licensure and post-marketing management
- Define and lead the execution of global regulatory CMC strategies for device & combination products to ensure successful approvals in key markets and Compliance throughout development and lifecycle.
3. REPORTING LINE
- Global Head of Regulatory CMC, TechOps
4. ROLES AND RESPONSIBILITIES
- Lead the global regulatory CMC strategy for combination products throughout their lifecycle, including early development, registration, post-marketing and compliance management.
- Provide technical guidance to CMC team and ensure integration of global combination product requirements into regulatory submissions in alignment with 21 CFR Part 4, EU MDR, ISO 14971, and ICH guidelines, incl. supplier notifications, biocompatibility and HFS
- Lead the creation of technical documentation and overarching global strategy document for device component
- Support and guide the authoring, review, and submission of regulatory dossiers for device-specific M3 sections, e.g. INDs, BLAs, MAAs, and global roll-out of post-approval changes (incl. assessment of change controls, management of Commitments etc.)
- Coordinate, write and review responses to global Health Authorities questions related to Device and combination drug product
- Lead regulatory interactions with global Health Authorities and the preparation of BBooks on CMC topics relevant for device & combination product
- Lead Notified Body (NB) submissions, responses, and renewals
- Provide strategic input on developmental activities on CMC/combination product for e.g., design control, DHF, human factor studies, and GMP interfaces.
- Ensures global CMC regulatory intelligence is built and captured across global CMC regulatory requirements for device and combination products
- Represent the company in external industry forums and contribute to shaping regulatory policy for combination products.
- Performs risk analysis for determination of probability of success for strategic regulatory CMC decisions, approves appropriate level of risk and mitigation for significant issues as required.
- Act as the Reg CMC interface on cross-functional combination product teams and establish strong partnerships to ensure collaboration with key internal stakeholders (RA, CMC, Supply Chain, Quality, Clinical etc.), and external organizations (contract manufacturers and development partners, consultants etc.) to ensure Reg CMC alignment and to integrate the global device strategy into submissions
- Ensures goals are met, processes are aligned to ensure efficiencies and to promote collaborative global cross-functional relationships.
- Ensure regulatory data and systems (e.g., Veeva RIMS, Veeva Quality Docs) are effectively leveraged for operational efficiency and compliance.
- Mentoring and developing regulatory CMC professionals to increase the device expertise within the organization.
5. SKILLS AND COMPETENCIES
- Deep expertise in global combination product regulations, including FDA (21 CFR Part 4), EMA (MDR/IVDR), and applicable ISO standards.
- Extensive experience leading combination product strategies and submissions from development through post-approval.
- Experienced in authoring and reviewing device related Module 3 sections and design history files
- Solid understanding of drug and device development processes, including design control, risk management, human factor studies, and GMP/QMS interfaces.
- Proven leadership skills in cross-functional team environments and global regulatory operations.
- Strategic mindset with ability to drive execution in a dynamic and complex regulatory landscape.
- Strong influencing, communication, and stakeholder management skills.
- Strong collaborative interpersonal, communication, presentation and meeting leading skills.
- Strong ability to work in a project-based environment and across cultural lines.
- Proactive strategic thinker; Continuous improvement mindset.
- Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
6. EDUCATION, EXPERIENCE AND QUALIFICATIONS
- Experience in the pharmaceutical/biotechnology industry, with relevant expertise in CMC and Device & Combination products Regulatory Affairs
- Experience in leadership/management of Regulatory CMC in the Device area and combination products activities with demonstrated organizational skills.
- Master degree or PhD in biotechnology, pharmaceutical sciences, biological science.
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At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
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