Senior Regulatory Affairs Associate
Flexible on location, however there will be occasions when you will need to attend meetings and work from our Vauxhall Bridge site.
This is a great opportunity to join a successful and growing global Pharmaceutical organisation and help shape the future of a diverse Regulatory Affairs function.
MAIN OBJECTIVES OF THE ROLE:
- To work on Regulatory Affairs projects as required to meet business needs
- To ensure compliance with EU, ICH and other harmonized standards
- To ensure Regulatory Compliance of the company’s products with all relevant legislation
- To assist in any area of regulatory affairs at global level
Main duties and responsibilities include:
- Create and/or support the development of regulatory strategies for new MAAs and product lifecycle maintenance activities for OTC medicines.
- Manage, execute and coordinate new MAA applications and product lifecycle maintenance activities (including variations, renewals and safety updates) for OTC medicines.
- Support the management of the assigned therapeutic category including product name strategy, the production of product information texts, review of claims, global advertising material and pack design.
- As part of the team ensure product registrations are correct and compliant with the relevant legislation.
- Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the European territories.
- Communicate with local and international regulatory authorities regarding applications and compliance issues.
- Interpret and implement (inter)national legislation, follow changes in (inter)national regulations and legislations and proactively manage impact of these changes.
- Participate to category and/or product meetings
- Analyse regulatory issues and inform relevant stakeholders of developments in national and EU regulations and legislation and provide regulatory intelligence.
- Provide support in maintaining the current Regulatory Systems used by the team.
- Develop and provide training of relevant procedural documents.
- Assist in the process of reporting and investigating critical nonconformities and opportunities for improvement.
- Bachelor or Master's degree in International Law, European Policies, Medical/Life Sciences or other relevant fields
- Postgraduate qualification desirable
- At least 3 years of experience in a relevant regulatory environment
- Self-motivated, flexible and open to changing requirements
- Highly driven with enthusiasm to meet requirements and cope under demanding pressure
- The ability to work autonomously and in team
- The ability to lead and support several concurrent projects/products
- The ability to priorities decisions and activities to ensure efficient use of resources and address critical issues impacting the business
- Excellent project management and administrative skills
- Excellent communicator in English. Additional language skills are preferred.
- Excellent problem-solving skills.
- Passion for products and regulatory compliance management
- Being thorough and focused
- Having a strong entrepreneurial spirit
- Being keen on innovation and creative thinking
We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.