The Director leads regulatory objectives, advice and strategy in alignment with department and corporate goals. He/she will guide multi-functional teams to ensure that regulatory requirements for the assigned products are achieved. He/she will act as the official liaison with European Regulatory Agencies and will lead preparation and conduct of meetings with European Regulatory Agencies.
He/she plans and leads regulatory document preparation for regulatory submissions in Europe and in International geographies including CTAs, MAAs, Variations, Orphan applications, PIPs. He/she keeps abreast of evolving regulatory procedures and practices.