6 Month Contract
il y a 2 semaines
Regulatory Affairs is a critical function within Reckitt: a key partner in developing the right portfolio strategy for brilliant innovation and activation in our markets.
We actively engage externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment, and we bring that regulatory intelligence back to RB to drive better informed business decisions. We lead the thinking internally about what is possible and put forward ideas that become reality, acting as stewards of our brands and our company to deliver compliant and competitively positioned products to the people we serve.
The Associate will enable delivery of NPDs to global markets by providing key skills and expertise in dossier creation, working to support an integrated approach to regulatory planning across innovation and will provide SME knowledge into your assigned projects. You will ensure that all regulatory activities are completed according to the best process, in a consistent approach across projects.
**Key responsibilities will include**:
- Manage a complex and diverse set of registration/regulatory requirements across multiple markets and brands to enable the strategic delivery of a global pipeline.
- Contribute to the development of regulatory strategies to enable successful registration in global markets with a focus on New Product Development
- Maintain and develop knowledge and intelligence across the Regulatory Function to build ‘right first time’ approach with respect to registrations globally.
- Collaborate with partner functions to agree market specific data requirements and delivery timelines
- Develop excellent working relationships with local (regional) regulatory colleagues to facilitate aligned regulatory plans and shared learnings to ensure efficient speed to market.
- Create strong and proactive relationships with all partner functions.
- Work collaboratively with Snr Manager/Manager in order to define and implement the regulatory strategy
- Assist in monitoring, collecting, interpreting and sharing with business partners, regulatory issues and trends that will impact RB products, policies and procedures. Assist in the development of strategies and plans of action to address them.
- Assist in the preparation of responses to address significant safety, regulatory and PR issues in the assigned Category
**Who you are**:
- Educated in a scientific field or equivalent experience. Honours degree is a plus.
- Minimum 1 year regulatory experience and knowledge in dossier / technical file creation, variations and renewals
- Ideally experience in medical products (preferably OTC) regulations. Other regulations would be a plus e.g. medical devices, cosmetics
- Understanding of global product development practice, rules, regulations and guidelines.
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.
- Ability to consistently deliver to time, cost and quality standards in a fast-paced environment
- Ability to work on own initiative and be a self-starter
- Excellent communication, influencing and stakeholder management skills
- Fluent in English, Dutch and a strong preference for French, or French language skills that can be developed
**Equality**:
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
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