Global Regulatory Affairs Manager

GLOBAL REGULATORY AFFAIRS MANAGER - BEDFORDSHIRE - 6 MONTH CONTRACT

An excellent opportunity has arisen to join a world leading global organisation, and they are currently looking for a GLOBAL REGULATORY AFFAIRS MANAGER based in Bedfordshire. This site is within commute to Milton Keynes.

We are currently recruiting a Global Regulatory Affairs Manager for the Oral Care Category. The successful candidate will lead the regulatory strategy, organisation and guidance for the Oral Care category's innovation programme and relevant strategic science group programmes.

KEY RESPONSIBILITIES

PROVIDES REGULATORY INPUT TO THE CATEGORY INNOVATION PROJECTS (PRE LOCK)

Supports to the Global Development Centres and Discover programs on innovation projects and emerging technologies
Provides regulatory reviews and assessments for the countries in which the product is to be marketed.
Is expert on regulatory developments worldwide which could affect the category's products, and ensures that these developments are incorporated into the category innovation programme

LEADS THE GLOBAL ORAL CATEGORY REGULATORY AFFAIRS NETWORK

Monitors regulatory activities in markets/challenges in/out
Prepares global regulatory summaries for specific product areas
Communicates information on issues, issue management, and regulatory news

MANAGES REGULATORY AFFAIRS FOR THE CATEGORY

Provides global regulatory updates on regulations affecting the category, gives training as required.
Is the global regulatory expert in the category claims co generation process.
Provides regulatory support to the management of globally relevant category issues and opportunities.
Anticipates regulatory challenges for the future which could drive the external influencing agenda for the category as input for the advocacy agenda, innovation plans.
Executes regulatory risk assessments, participates in stress tests

IDENTIFIES AND MANAGES CONSULTANTS, EXTERNAL RA EXPERTS RELATED TO THE INNOVATION PROJECTS OF THE CATEGORYsetting goals, plan
Stakeholder mgt and reporting(internal as business partner, external as advocate)
Provides input to global regulatory affairs strategy

IS THE REGULATORY AFFAIRS EXPERT ON ADVOCACY TOPIC

DEVELOPS AND MAINTAINS EXCELLENT INTERFACES WITH INTERNAL AND EXTERNAL RELEVANT PARTNERS

ESSENTIAL EXPERIENCE, SKILLSpreferably an M.S. or PhD in Biological Science, Toxicology, Environmental Science OR Chemistry or equivalent.
Significant experience of the regulatory requirements that govern the medical device industry, in the oral care area.
Significant experience in supporting the development, research, and regulatory affairs functions
Experience of working in an external environment (such as trade associations, Regulatory Authorities, etc.)

As we receive such a high volume of applications every day, regretfully, we are only able to respond to successful candidates.