RCC apma manager

Novartis pharma gmbh

• Holzkirchen

neues Angebot (20/05/2020)

stellenbeschreibung

Job Description 200+ submissions to be done, more than 100 approvals to be granted, This is part of how RCC Africa contribute to business. This is your chance to help reimagine medicine in 2020. Sandoz is looking for dedicated individuals to join our Regulatory Competence Center team and enhance access to medicine to all patients in Africa

Your Responsibilities

:

• accountable for driving strategic regulatory initiatives for the respective countries (countries defined under scope of responsibilities) and is responsible for the development and execution of local/regional regulatory strategies with country dra units, sandoz develop-ment/maintenance centers and international development partners to secure on-time submis-sion of sandoz products. - accountable for ensuring each molecule has a defined regulatory strategy and in full compli-ance with government, regulations and standards set by sandoz. - responsible for overseeing government product inquires and response strategies for deficien-cy letters in close collaboration with country dras and sandoz development centers. - in collaboration with sandoz licensing regulatory department and country organizations, is responsible for new product assessments and due-diligence activities with local and interna-tional partners. - accountable for evaluation of changes in local and regional regulations in the respective clus-ter and assessment of impact of new regulations on sandoz portfolio and development pro-jects. - representative for the respective countries to global product development, project manage-ment, portfolio/ launch management, technical operations and participates in relevant cluster meetings with commercial functions. - accountable for regulatory compliance in the respecting cluster - following good regulatory practice and internal sandoz quality standards - accountable for full compliance of internal regulatory tools and systems minimum requirements what you'll bring to the role:
• bachelor's degree in chemistry, biochemistry, pharmacology, pharmacy or other relevant disciplines. - fluent in english (spoken, written and presentation);

german and other languages would be an asset - minimum 3-4 years of regulatory experience at global or country level, preferably working in the generic field within the cluster or apma (not obligatory). - solid understanding of generic drug development process, ich guidelines, local and re-gional 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 man-agement, as appropriate. - excellent management, interpersonal, scientific / technical writing, advanced communica-tion and negotiation skills. - good knowledge of microsoft office suit why consider sandoz? our number 1 priority is to pioneer patient access to better healthcare. we are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an fda-cleared digital therapeutic. and we never stop asking:

how can we continue to pioneer access in an ever-more digital and global world? the answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks. sandoz, a novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. imagine what you could do at sandoz! commitment to diversity & inclusion:

sandoz, a novartis company, embraces diversity, equal opportunity and inclusion. we are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. join our novartis network:

if this role is not suitable to your experience or career goals but you wish to stay connected to learn more about novartis and our career opportunities, join the novartis network here:

division sandoz business unit product dev sz location deutschland site holzkirchen (bei münchen) company/legal entity hexal ag functional area forschung & entwicklung job type vollzeit employment type unbefristet shift work nein

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