Based in Central London with some home working flexibility, this position would be ideal for candidates with strong non-EU region experience, candidates with strong EU experience would also be considered as long as they have had a small amount of non-EU region experience also.
- Undertaking International Regulatory strategies for product lifecycle, including product development and post-marketing all therapeutic areas, biologics (30%) and small molecules (70%). To work cross-functionally within Regulatory, as well as with Commercial, Global Marketing, Clinical Development and so forth to identify what international regulatory requirements are necessary and how to best move forward to meet project plans.
- Ensures implementation of the strategy to ensure proper facilitation and preparation of International regulatory documents and various submissions, as well as any compliance matters
- To successfully communicate with international Health Authorities
- Executes the Regulatory submissions to support product development and approval efforts for all post-market products in non-US and non-EU countries (such as focusing on the emerging markets; Asia Pacific, Latin America, Russia, India, etc. but also including other developed countries such as Australia, S. Africa).
- Responsible for staying current with revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
For further information please get in touch with Natalie Hopkins; 02071 835 059 - firstname.lastname@example.org
- Degree in a scientific discipline. Preferred advanced degree (MS/PharmD/PhD)
- Regulatory international bio/pharmaceutical experience
- Solid knowledge of regulations, policies, procedures, drug development guidelines and compliance for all emerging and selected developed markets
- Excellent written and oral communication skills required
- Knowledge of eCTD