Senior Executive, Regulatory Affairs (API)

Job Description

1886! We have more than 130 years of experience treating patients.Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.Your responsibilities:Your responsibilities include, but are not limited to: To assist in timely submission of new DMF submissions and DMF ammendments for the required regions EU, US, CN, ROW etc) to finalize deficiency responses in time and provide regulatory support to contrib-ute to global API regulatory submissions and strategies. Prepare CMC responses to health authority questions during development, registration and product lifecycle. Assuring technical congruency and regulatory compliance and meeting agreed upon timelines throughout project lifecycle. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible. Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Actively participate as a member of the global Regulatory CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Establish and maintain sound working relationships with partners and customers. Regulatory assessment of change control proposal received from manufacturing sites. Evaluation of DMF from external API supplier in line with HA requirements and as per established procedures. Regulatory Evaluation and Risk Management of Potential Mutagenic Impurities in Externally Sourced and Internally Manufactured APIs or API changes Maintenance of various lists/documents submission records, communications, DMF submission records. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends. Minimum requirements What you ll bring to the role: University or College Degree in any field or life science with relevant industry experience or comparable degree Minimum 4-6 years experience in the Pharmaceutical area, specifically in Regulatory Affairs in API are preferred Organizational awareness and experience working cross-functionally and in global teams is a plus Ability to work under pressure, demonstrating initiative and flexibility High level understanding of Regulatory quality, standards and policies. Attention to detail and quality focused Excellent communication and interpersonal skillsWhy 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.Join our Novartis Group 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: https://talentnetwork.novartis.com/network,

Keyskills :
missales customer relationscustomer service deliverycontinuous improvement facilitation global teamschange control