Associate Director, Emea Global Regulatory Policy

1 month ago

High Wycombe, United Kingdom Johnson & Johnson Full time

For Johnson & Johnson's Global Regulatory Affairs team, we are currently hiring an Associate Director of Global Regulatory Policy & Intelligence (GRPI) that can be based in any of our J&J/Janssen hubs in EMEA. We believe in strong team collaboration both locally and globally, which is why we have a hybrid work model by default.

In this role, you will be a member of a team of regional policy and intelligence professionals developing high-quality regulatory policy positions and advocacy strategies based on an understanding of regulatory and legislative trends and issues that have the potential to impact J&J Pharmaceutical Research & Development.

The decentralized nature of Johnson &Johnson’s business and the range of therapeutic categories in which it operates means this role will encompass a broad range of responsibilities that will need addressing with equal importance and measure of priority.

With this diversity, the role delivers interesting challenges and complexities that offer the opportunity to scope and define its dimension to enable us to shape and influence the current and emerging regulatory environment.

**Main duties and responsibilities within GRPI**:
**Regulatory Policy**:

- Proactive & reactive policy development from the global and regional perspective
- Participate in relevant J&J global and regional policy working groups
- Provide advice on and interpretation of current regulatory guidelines and procedures as well as emerging regulatory/legislative issues that impact or affect J&J businesses or products.
- Liaise with the regional regulatory affairs organisation and establish regular communication forums for dissemination of regulatory intelligence and information on emerging policy issues, including action plans
- Support effective approaches to regulatory policy activities, including generating positions, influencing plans, tracking and internal communication
- Co-ordinate input into commenting on regulatory and legislative texts to help shape and influence key regulatory policies
- Seek and drive external opportunities to advocate the company's position about regulatory policy
- Support internal functions and/or groups through consultation and training on specific regulatory intelligence issues
- Participate in and represent the company position in relevant trade association meetings

**Regulatory intelligence**:

- Collaborate and partner with GRPI Intelligence & Knowledge Management to ensure effective and timely dissemination of EMEA Regulatory Information, Intelligence, and Knowledge
- Communicate regularly with local and regional regulatory staff and partners regarding emerging regulatory issues and intelligence obtained through research, meetings, and external forums.

**Decision-making and problem-solving**:

- Proactively identify issues and problems, be able to identify and assess risk and the chances of success, and offer solutions and recommendations
- Find a solution to resolve regulatory or business issues and demonstrate an understanding of the impact of decisions taken
- Interpret the applicability of regulatory legislation and processes to propose innovative solutions to regulatory challenges and areas of policy
- Ability to work across businesses and cultures on a worldwide basis to ensure global alignment and compliance with key partners
- Develop effective and highly communicative relationships across highly sophisticated organizations of multifunctional personnel

**Qualifications**:
**Key Qualifications and Experience required**:

- Experience in regulatory policy activities gained within the EMEA region, national health authority, industry, or trade associations.
- Solid understanding of the regional regulatory framework and how that applies to pharmaceutical and healthcare product development.
- Knowledge of regulatory texts, and legal texts, and extensive experience in regulatory affairs.
- Experience in engaging with health authorities, professional organizations, or trade associations.
- Proven success in developing and driving positioning and advocacy campaigns.
- Ability to drive, challenge and improve the regulatory environment

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