Regulatory BD Manager (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit Product Dev SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 245723BR


Stellenbeschreibung

The Global Regulatory Business Development Manager supports the in-licensing process by executing regulatory due diligence on dossiers from license partners and setting smart registration strategies for global submissions of in-licensed medicinal products in alignment with internal and external interfaces.

• Ensures only high quality developments, dossiers and registrations are purchased, which are suitable for applying for registrations and allow timely product launches in global markets.
• Confirms that developments and/or dossiers (chemical-pharmaceutical) or registrations from external business partners comply with regulatory requirements. Prepares due diligence summaries of the assessments, which support the organization to decide on in-licensing deals.
• Identifies regulatory risks and cooperates with external partners and Global BD Managers to mitigate identified risks. Follows up on implementation of the mitigation plans.
• Support contract negotiations where applicable by providing the regulatory requirements according to the scope to be included in the contract.
• Advises the development team of licensors to prepare development plans and registration files that follow international (e.g. ICH) and regional requirements for global submissions.
• Defines regulatory strategies for new marketing authorization applications and product launch preparations (e.g. variations). Coordinates the execution of registration procedures, ensures that the timelines are met and keeps proper alignment between all regulatory interfaces and the license partners.
• Liaises 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.
• Acts as the regulatory lead on in-licensing deals by monitoring & controlling execution of the registration procedures until successful market entry.
• Coordinates and/or prepares timely high quality responses to health authority questions by involving the license partner and/or specific Sandoz development functions.
• Reports regulatory project progress to internal stakeholders.



Research & Development


Mindestanforderungen

• 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
• At least 5 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.
• Good 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.
• 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
• Strategic thinking
• Excellent analytical and problem solving skills with strong attention to details.

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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