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18 days ago
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Senior Regulatory Project Manager


Johnson & Johnson
Location: High Wycombe
Job type: Permanent
Category: Project Management Jobs
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At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science.

Janssen Research & Development, LLC discovers and develops creative medical solutions to address meaningful unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

Role purpose

You will provide regulatory support for a portfolio of promoted and non-promoted products ensuring that Regulatory documents are prepared in line with MHRA and HPRA requirements and accepted timelines.

You will manage all regulatory queries to ensure they are addressed promptly and you will be responsible for the content of the local labelling documents released to prescribers.

Key activities

* You will ensure product information for prescribers and patient line are released within strict timelines

* Preparing and distributing labelling documents within stipulated timelines

* Conducting Quality checks on submissions for labeling, post authorization of Regulatory approvals

* Working with a marketing group on a supported product to support form regulatory.

* Lifecycle labeling maintenance

* Preparing for and running local procedures following the EMEA Regulatory Affairs

* Partnering with allocated commercial teams to provide regulatory expertise and support

Qualifications

Essential technical knowledge, skills and experience

Are you are an experienced project manager? Do you have the following background and experience? If so we would like to hear from you:

* You will have excellent attention to detail and will have a positive mindset in ensuring delivery of your work error free.

* Your Regulatory Affairs experience will be at operational level

* Strong persuading and influencing skills, negotiating skills will be some of your key attributes

* You have strong data gathering and analytical skills that will be essential to your success

* Having studied a University Degree in Pharmacy, Biology, Chemistry or related Life Science

* If you are a registered member of the Organisation for Professionals in Regulatory Affairs would be a distinct advantage.

* Direct experience and strong knowledge of UK and Irish regulatory requirements and guidelines and a positive outlook on productive relationships with these bodies

Our mission drives us, our patients inspire us, we collaborate with the world for the health of everyone in it. Growing on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All applicants who are qualified will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United Kingdom-England-High Wycombe-
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
1805697707W
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science.

Janssen Research & Development, LLC discovers and develops creative medical solutions to address meaningful unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

Role purpose

You will provide regulatory support for a portfolio of promoted and non-promoted products ensuring that Regulatory documents are prepared in line with MHRA and HPRA requirements and accepted timelines.

You will manage all regulatory queries to ensure they are addressed promptly and you will be responsible for the content of the local labelling documents released to prescribers.

Key activities

* You will ensure product information for prescribers and patient line are released within strict timelines

* Preparing and distributing labelling documents within stipulated timelines

* Conducting Quality checks on submissions for labeling, post authorization of Regulatory approvals

* Working with a marketing group on a supported product to support form regulatory.

* Lifecycle labeling maintenance

* Preparing for and running local procedures following the EMEA Regulatory Affairs

* Partnering with allocated commercial teams to provide regulatory expertise and support

Qualifications

Essential technical knowledge, skills and experience

Are you are an experienced project manager? Do you have the following background and experience? If so we would like to hear from you:

* You will have excellent attention to detail and will have a positive mindset in ensuring delivery of your work error free.

* Your Regulatory Affairs experience will be at operational level

* Strong persuading and influencing skills, negotiating skills will be some of your key attributes

* You have strong data gathering and analytical skills that will be essential to your success

* Having studied a University Degree in Pharmacy, Biology, Chemistry or related Life Science

* If you are a registered member of the Organisation for Professionals in Regulatory Affairs would be a distinct advantage.

* Direct experience and strong knowledge of UK and Irish regulatory requirements and guidelines and a positive outlook on productive relationships with these bodies

Our mission drives us, our patients inspire us, we collaborate with the world for the health of everyone in it. Growing on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All applicants who are qualified will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United Kingdom-England-High Wycombe-
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
1805697707W
Apply

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