As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation for active ingredients/intermediates.
Your responsibilities will include: Lead, coach and mentor associates. Ensure sufficient training and development opportunities to maximize regulatory competence. Take responsibility for financial targets included but not limited cost center responsibility. Ensure and/or support timely and accurate reporting of regulatory activities. Perform and/or support analyzing group performance and making recommendations for improvement the team. Coordinate the preparation and execution of regulatory documents. Ensures regulatory CMC submissions are of high quality, consistent and complete, and comply with current global regulatory standards. Formulate, lead and drive global regulatory strategy with a focus on maximizing the business benefit balanced with regulatory compliance for drug substances. Generation, review and approval of internal regulatory guidance documents, protocols, reports within assigned projects. Establish and maintain sound working relationships with colleges, partners and customers. Provide regulatory guidance to cross-functional teams, and determine regulator impact for changes in chemistry, manufacturing, and control procedures. Support or/and lead global regulatory projects/initiatives. Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions as well as for new technical trends. Responsibility for transfer of knowledge and experiences to the organization. Liaise under minor supervision with regulatory agencies and represent the company in regulatory meeting and discussions. Work according to internal and external guidance, SOPs and respective timelines. What you'll bring to the role: PhD (natural science: chemistry, pharmacy, biology or related substances) with at least 3 years work related post-doctoral / industrial experience or Master/BSc (natural science: chemistry, pharmacy, biology or related substances) with at least 3 years of work related experience including people management experience. Leadership experience within regulatory affairs function. Broad knowledge on Module 3. Broad knowledge of regulatory guidelines. Good knowledge of relevant software tools. Good skills in presentation and scientific/technical writing. Good documentation skills and able to understand and exactly follow written procedures. Fluent oral and written English. Fluent Spanish. Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion: Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
#J-18808-Ljbffr