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 plans. This includes 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 including but not limited to 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 for the team.Coordinate the preparation and execution of regulatory documents. Ensure 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 colleagues, partners and customers. Provide regulatory guidance to cross-functional teams, and determine regulatory impact for changes in chemistry, manufacturing, and control procedures. Support or 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 meetings and discussions.Work according to internal and external guidelines, 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.#J-18808-Ljbffr