Group Manager RCC APAC (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit Product Dev SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 252687BR


Stellenbeschreibung

• Be responsible for leading cluster regulatory group, in defining and implementing regional regulatory strategies in the registration and approval of new innovative/generic pharmaceutical products in the cluster.
• This role provides strategic guidance and direction to Sandoz Development/Maintenace Centers, ComOps, Tech.Ops, Third party development teams and acts as a primary interface between Sandoz Country Organizations and Sandoz Global functions1
• Leadership of the cluster regulatory group (+5 FTE), including staff training and people development. Indirect management of the country DRA Heads in the cluster.
• Accountable for driving strategic regulatory initiatives in the territory and is responsible for the development and execution of local/regional regulatory strategies with country DRA units, Sandoz Development/Maintenance Centers and international development partners to secure on-time submission of Sandoz products.
• Accountable for ensuring each molecule has a defined regulatory strategy and in full compliance with government regulations and standards set by Sandoz. Responsible for overseeing government product inquires and response strategies for deficiency letters in close collaboration with country DRAs and Sandoz Development Centers.
• Accountable for setting key performance metrics for product registration and launch performance in the respective cluster, ensuring alignment with country organizations and global functions and ensuring objectives are met, and functional excellence including compliance is achieved.
• In collaboration with Sandoz Licensing Regulatory Department and Country Organizations, is responsible for new product assessments and due-diligence activities with local and international partners.
• Ensure systems and procedures are in place to monitor and evaluate changes in local and regional regulations in the respective cluster and assessment of impact of new regulations on Sandoz portfolio and development projects.
• Drives contact and relationship to local regulatory authorities and to regulatory units of industry associations.
• Representative for the respective cluster to global product development, project management, portfolio/ launch management, Technical Operations and participates in relevant cluster leadership meetings with commercial functions.



Research & Development


Mindestanforderungen

• Bachelor’s degree in Chemistry, Biochemistry, Pharmacology, Pharmacy or other relevant disciplines. Advanced science degree preferred.
• Fluent in English (spoken, written and presentation); German and other Asia Pacific languages would be an asset
• Minimum 5 years of regulatory experience at global or country level, preferably working in the generic field within Asia Pacific region (not obligatory).
• Leadership experience; motivational leader with a strong focus on people development, growing future talent and inspires creativity and innovation. Sets clear vision and direction and aligns team.
• Solid understanding of generic drug development process, ICH Guidelines, local and regional regulations, with the ability to interpret and apply policy.
• Experience in OTC and natural health products would be an asset.
• Strong analytical skills and solves problems proactively with minimal supervisory input, anticipating and identifying regulatory risks and makes recommendations to upper management, as appropriate.
• Excellent leadership skills, management, interpersonal, scientific / technical writing, advanced communication and negotiation skills.
• Good knowledge of Microsoft Office Suit


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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