1. PURPOSE OF THE FUNCTION
1. Lead the Regulatory CMC strategies for Device & Combination Drug Products
2. Provide strategic leadership for combination products across development, licensure and post-marketing management
3. 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.
2. REPORTING LINE
4. Global Head of Regulatory CMC, TechOps
3. ROLES AND RESPONSIBILITIES
5. Lead the global regulatory CMC strategy for combination products throughout their lifecycle, including early development, registration, post-marketing and compliance management.
6. 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
7. Lead the creation of technical documentation and overarching global strategy document for device component
8. 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.)
9. Coordinate, write and review responses to global Health Authorities questions related to Device and combination drug product
10. Lead regulatory interactions with global Health Authorities and the preparation of BBooks on CMC topics relevant for device & combination product
11. Lead Notified Body (NB) submissions, responses, and renewals
12. Provide strategic input on developmental activities on CMC/combination product for e.g., design control, DHF, human factor studies, and GMP interfaces.
13. Ensures global CMC regulatory intelligence is built and captured across global CMC regulatory requirements for device and combination products
14. Represent the company in external industry forums and contribute to shaping regulatory policy for combination products.
15. 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.
16. 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
17. Ensures goals are met, processes are aligned to ensure efficiencies and to promote collaborative global cross-functional relationships.
18. Ensure regulatory data and systems (e.g., Veeva RIMS, Veeva Quality Docs) are effectively leveraged for operational efficiency and compliance.
19. Mentoring and developing regulatory CMC professionals to increase the device expertise within the organization.
4. SKILLS AND COMPETENCIES
20. Deep expertise in global combination product regulations, including FDA (21 CFR Part 4), EMA (MDR/IVDR), and applicable ISO standards.
21. Extensive experience leading combination product strategies and submissions from development through post-approval.
22. Experienced in authoring and reviewing device related Module 3 sections and design history files
23. Solid understanding of drug and device development processes, including design control, risk management, human factor studies, and GMP/QMS interfaces.
24. Proven leadership skills in cross-functional team environments and global regulatory operations.
25. Strategic mindset with ability to drive execution in a dynamic and complex regulatory landscape.
26. Strong influencing, communication, and stakeholder management skills.
27. Strong collaborative interpersonal, communication, presentation and meeting leading skills.
28. Strong ability to work in a project-based environment and across cultural lines.
29. Proactive strategic thinker; Continuous improvement mindset.
30. Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
5. EDUCATION, EXPERIENCE AND QUALIFICATIONS
31. Experience in the pharmaceutical/biotechnology industry, with relevant expertise in CMC and Device & Combination products Regulatory Affairs
32. Experience in leadership/management of Regulatory CMC in the Device area and combination products activities with demonstrated organizational skills.
33. Master degree or PhD in biotechnology, pharmaceutical sciences, biological science.
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Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.
This job is eligible to participate in our short-term and long-term incentives program.
The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.