Head of Post-marketing Cmc Regulatory

Il y a 5 mois


Gent, Belgique Argenx Temps plein

Key Accountabilities and Responsibilities:
Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to support

development and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out to

other territories world-wide. Critical to this role are strong CMC regulatory strategy and leadership skills.
- Lead the global post-marketing CMC strategy and CMC regulatory team.
- Provide CMC regulatory affairs leadership, oversight and strategy in support of argenx’ products,

including but not limited to CMC regulatory strategies, regulatory requirements in global and regional

markets, regulatory strategic development plans and risk assessments, and advice on Health Authority

interactions.
- Lead Global Health Authorities interaction preparations on CMC strategy topics.
- Provide guidance on the scientific/technical requirements for CMC and GMP related submissions to

pending BLAs, MAAs and Life Cycle Management activities (annual reporting, variation planning and

filing, change impact assessment).
- Ensure post-marketing commitments strategy, follow-up and submission activities are planned and

executed;
- Review CMC and GMP related submission documents to assure compliance with regulatory standards

and scientific/technical requirements and ensure their appropriateness for use in global regulatory

submissions.
- Ensures global CMC regulatory intelligence is built and captured across global CMC regulatory

requirements.
- 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.
- Establishes strong cross-functional partnerships to ensure collaboration with key internal stakeholders

(RA, CMC, Supply Chain, Quality), and external organizations (contract manufacturers, regional

regulatory partners etc).
- Ensures goals are met, processes are aligned to ensure efficiencies and to promote collaborative global

cross-functional relationships.
- Be proficient in the tools and systems needed for the function including and not limited to Veeva RIMS

and Veeva Quality docs - continuously seeking efficiencies in using these

**Qualifications**:

- In-depth knowledge of global CMC regulations for biologic compounds, as well as devices, and the

Module 2/ Module 3 eCTD requirements.
- Combination product experience desired (Prefilled drug delivery systems, drug/device systems) is a plus.
- Experience in the biologic life-cycle activities desired.
- Comprehensive knowledge of biologic and drug development process, pharmaceutical technology,

manufacturing processes, GMP and related issues.
- Highly knowledgeable in industry trends for study reports and dossier preparation (e.g.,

IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).
- Strong proven hands-on CMC Regulatory Affairs experience and knowledge of CMC regulatory

submission requirements for global filings (FDA and/or EMA, etc.) is required.
- Strong understanding of pharmaceutical development, the regulatory environment, project

management, and medical terminology.
- Have a solution-oriented approach to problem solving;
- Ability to work on complex projects and within cross-functional teams with mínimal supervision
- Proactive strategic thinker; Operationally minded
- Strong analytical, problem solving, organizational and negotiation skills.
- Strong collaborative inter-personal, communication, presentation and meeting leading skills.
- Strong ability to work in a project-based environment and across cultural lines.
- Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,

Excel, PowerPoint, and Outlook).

Experience
- 15+ years of experience in the pharmaceutical/biotechnology industry, 10 of which are in CMC

Regulatory Affairs.
- 8+ years Leadership/management of Regulatory CMC activities and demonstrated

organizational/planning skills.

Educational Qualifications
- Master degree or PhD in biotechnology, pharmaceutical sciences, biological science

**Offer**:

- A competitive salary package with extensive benefits
- Front seat in the development of therapeutic antibodies
- A work environment in a human-sized, dynamic and rapidly growing biotech company
- Reporting to global CMC management
- Location: global

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