Regulatory Affairs Manager LATAM RCC (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit Product Dev SZ
Standort Holzkirchen (bei München)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Unbefristet
StellenID 252520BR


Stellenbeschreibung

• Ensure regional regulatory input on development; consistency and communication of global regulatory strategy for the assigned product from development to launch phase
• Ensure regional regulatory input to BDL Global and Regional partners to guarantee requirements are provided in order to support submission and registration in Latin America countries
• Ensure understanding of the regional external regulatory competitive environment, trends and legislation to adapt regulatory strategy and to meet future requirement accordingly (trend analysis);
• Ensure top quality across regional regulatory submissions and planning for dossiers preparation;
• Ensure compliance with applicable internal guides and pharmaceutical legislations with regard to CMC of pharmaceutical Products for the region.
• Required regulatory support for manufacturing business units and Functional guidance to CO DRA units in Region.
• Support CO DRA units to answer HA LoQA timely and accordingly
• Efficient execution and processes in accordance with the Guide to Good Regulatory Practice.
• Provide support to Regional Business through relevant information and timely performance to meet a target



Research & Development


Mindestanforderungen

• Degree in a Life Science discipline, higher degree as advantage (PhD, MBA)
• Excellent spoken and written English as must, Spanish and/or Portuguese as advantage.
• Pharmaceutical industry global regulatory experience, Latam region countries and generic market as advantage;
• Knowledge in pharmaceutical regulations, particular related to Region;
• Experience on development and preparation of successful regional regulatory strategies
• Excellent written and spoken communication skills
• Regulatory Business –knowledge in drug regulatory affairs and project management
• Know how on Quality and Pharmaceutical Technology.
• Good interpersonal skills, multi-cultural experience as advantage
• Ability to lead and work in multidisciplinary/multicultural teams
• Awareness of current trends in Regulatory Affairs.
• Business orientation and strategic thinking.
• Good planning and organizational skills

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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