Regulatory Affairs Officer - Promotional & Non-promotional Materials Review
Location: Reading, UK With this exciting opportunity within Regulatory Affairs, you will be responsible for the provision of high-quality promotional and non-promotional review services to internal stakeholders, which conform to all relevant legal requirements, ABPI & IPHA Codes of Practice, company guidelines and policies. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities:
1. Promotional and non-promotional materials review and internal stakeholder support Requirement for full compliance with company procedures, ABPI and IPHA Codes of Practice, and industry guidance. Establish and cultivate a good working relationship with internal customers such as Commercial, Medical and Medical Governance colleagues to ensure that the services provided are relevant to the business needs. To complete Regulatory Review and scientific accuracy of Sanofi marketed/pre-launch products and related disease area materials to ensure they comply with the relevant UK and Irish Codes of Practice and Sanofi policies. Attend brand planning and strategy discussions/meetings to provide regulatory material review input. Respond to internal enquiries in relation to the material review process/good material review practice in a timely and effective manner. Highlight potential issues with materials at the conceptual stage of development. Lead or participate in team projects. 2. Maintenance of information resources Produce and update Prescribing Information related to promoted products. About you:
Degree educated with a scientific discipline (or equivalent) or proven relevant experience within the regulatory environment. Competent in the use of PromoMats is desirable but not a requirement. Excellent written and verbal communication skills and interpersonal skills. An ability to understand, analyse and communicate relatively complex pharmacy, pharmacological, and clinical information about Sanofi products in a systematic, fair and balanced way. Accuracy and an eye for detail working with technical clinical data and material review. Able to prioritise with the appropriate sense of urgency based on customers’ and business needs; excellent time management skills. Application of sound professional judgement to ethical issues and make appropriate informed decisions without supervision. Able to quickly pick-up on new therapy areas and disseminate information in a clear and accurate manner. Ability to work under pressure, independently and as part of a team, in an open and professional manner, delivering high-quality work to meet timelines. Demonstrate the ability to interact professionally with key experts, negotiate on content and make constructive suggestions. Why choose us?
Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognises your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources. #LI-EUR Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our
ALL IN video
and check out our Diversity Equity and Inclusion actions at
sanofi.com !
#J-18808-Ljbffr
Location: Reading, UK With this exciting opportunity within Regulatory Affairs, you will be responsible for the provision of high-quality promotional and non-promotional review services to internal stakeholders, which conform to all relevant legal requirements, ABPI & IPHA Codes of Practice, company guidelines and policies. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities:
1. Promotional and non-promotional materials review and internal stakeholder support Requirement for full compliance with company procedures, ABPI and IPHA Codes of Practice, and industry guidance. Establish and cultivate a good working relationship with internal customers such as Commercial, Medical and Medical Governance colleagues to ensure that the services provided are relevant to the business needs. To complete Regulatory Review and scientific accuracy of Sanofi marketed/pre-launch products and related disease area materials to ensure they comply with the relevant UK and Irish Codes of Practice and Sanofi policies. Attend brand planning and strategy discussions/meetings to provide regulatory material review input. Respond to internal enquiries in relation to the material review process/good material review practice in a timely and effective manner. Highlight potential issues with materials at the conceptual stage of development. Lead or participate in team projects. 2. Maintenance of information resources Produce and update Prescribing Information related to promoted products. About you:
Degree educated with a scientific discipline (or equivalent) or proven relevant experience within the regulatory environment. Competent in the use of PromoMats is desirable but not a requirement. Excellent written and verbal communication skills and interpersonal skills. An ability to understand, analyse and communicate relatively complex pharmacy, pharmacological, and clinical information about Sanofi products in a systematic, fair and balanced way. Accuracy and an eye for detail working with technical clinical data and material review. Able to prioritise with the appropriate sense of urgency based on customers’ and business needs; excellent time management skills. Application of sound professional judgement to ethical issues and make appropriate informed decisions without supervision. Able to quickly pick-up on new therapy areas and disseminate information in a clear and accurate manner. Ability to work under pressure, independently and as part of a team, in an open and professional manner, delivering high-quality work to meet timelines. Demonstrate the ability to interact professionally with key experts, negotiate on content and make constructive suggestions. Why choose us?
Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognises your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources. #LI-EUR Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our
ALL IN video
and check out our Diversity Equity and Inclusion actions at
sanofi.com !
#J-18808-Ljbffr
