Role / Title / level of resource needed:
Estimated Project Initiation Date:
Already started ? ASAP
The duration of the project:
Long-term partnership ending 2023
Cap on hours:
60h month (flexible for Q4-21 and expected to be reduced during Q1-22 to 30h/month)
6 months with option to renew
CV - Cardiovascular
Description of services required:
Strategic advice for RoW MAA submissions in the following markets: Australia, Philippines, New Zealand, Indonesia, Singapore, Malaysia, Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama, South Korea, Mexico, Brazil, Argentina, Israel, Japan, Pakistan, Russia, South Africa, Thailand, India, Bangladesh, Turkey, Vietnam
Description of expertise required:
International Markets Regulatory affairs expert will have a broad understanding of regulatory science and requirements across international regions, and will have several years supporting submissions in these regions, particularly with emerging markets. The expert will provide strategic guidance to our clients and our delivery teams on requirements and submissions, including submissions of new product applications, across international regions.
An in depth knowledge of international requirements for regulatory affairs is critical for success in this role.
Key Skills and Responsibilities
- Creating and performing regulatory intelligence surveys, providing an objective assessment of intelligence data, communicating regulatory requirements, and proposing submissions strategies to clients.
- Ability to develop International Regulatory Submission Strategies to meet client needs for a wide variety of products/projects.
- Supporting Project leads in working local market Regulatory Affairs experts to optimise strategies for specific submissions
- Guiding delivery teams in the creation of International dossiers
- Identifying and mitigating risk with respect to international submissions
- Ensuring effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
- Coaching, mentoring and leading regulatory teams to ensure objectives are successfully delivered to time and quality.
- Monitors and keeps abreast of key changes in the regulatory environment of International markets; support and advise accordingly.
- Broad background in pharmaceutical business and experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
- Demonstrations of and management experience.
- Agency: Achieva Group Limited
- Contact: Lewis Coulson
- Phone: 01727 811 634
- Reference: BH-32423
Website: Achieva Group Limited
- Posted: 7th October 2021
- Expires: 4th November 2021