Regulatory Business Development Manager

Job Description

Hexel AG are looking to hire a Global Regulatory Business Development Manager to support merger and acquisition (M&A) deals & in-licensing projects by executing regulatory due diligence on dossiers and setting smart registration strategies for global submissions of in-licensed medicinal products and with specific focus on M&A deals in alignment with internal and external interfaces.

Your responsibilities will include:
• Ensuring that only high-quality developments, dossiers and registrations are purchased, which are suitable for applying for registrations and allow timely product launches in global markets.
• Confirming that developments and/or dossiers (chemical-pharmaceutical) or registrations from external business partners comply with regulatory requirements. Preparing due diligence summaries of the assessments, which support the organization to decide on in-licensing deals.
• Identifying regulatory risks and cooperating with external partners and Global BD Managers to mitigate identified risks. Following up on implementation of the mitigation plans.
• Supporting contract negotiations where applicable by providing the regulatory requirements according to the scope to be included in the contract.
• Advising the development team of licensors to prepare development plans and registration files that follow international (e.g. ICH) and regional requirements for global submissions.
• Defining regulatory strategies for new marketing authorization applications and product launch preparations (e.g. variations).
• Liaising with the license partner and Sandoz development functions to prepare registration packages (CTD Modules 2-5) for global new applications and variations in early life cycle stages.
• Acting as the regulatory lead on in-licensing deals by monitoring & controlling execution of the registration procedures until successful market entry.
• Managing M&A deals, leading them from early due diligence towards submission or MA transfer and launch.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Pharmacy graduate or comparable grade in Natural/Life Sciences (e.g. (Bio)-Chemistry, Biology)
• Fluent in English on business level with excellent spoken/written communication skills. Fluent German skills are mandatory.
• At least 7 years of experience in pharmaceutical industry with the majority in Drug Regulatory Affairs working in an international environment managing different scopes (e.g. RU, EU, BR, CA). Experience with medical devices and food supplements are a plus.
• Excellent pharmaceutical knowledge (analytical, development, manufacturing and safe use of medicinal products and medical devices).
• Deep knowledge of CTD dossier for suitable preparation of global registration packages consisting of the pharmaceutical chemical documentation of medicinal products. Experience in compiling these sections from scratch.
• Strong interpersonal and communication skills and experience in negotiating with 3rd party (license) partners
• Experience in working with internal and external stakeholders at all levels.
• Prior experience with M&A deals mandatory