Senior Associate EMEA Regulatory Affairs. in Johnson & Johnson at High Wycombe, England, United Kingdom

This listing is about Johnson Johnson in High Wycombe, England, United Kingdom
in 2022

About the job

Europe, Middle East and Africa (EMEA) Regulatory Affairs is looking to recruit a Regulatory Affairs Senior Associate / Regulatory Scientist within the Neuroscience, Cardiovascular, Metabolism and Retinal (NCM&R) therapy area team This person will be responsible to provide support to the EMEA Regulatory Liaison and the EMEA Therapeutic Area Leader for a variety of regulatory activities for products within the NCM&R portfolios.

Description

This is a varied role that will potentially involve activities such as supporting centralised marketing authorisations applications for new products (including small molecules, biologics and/or GMOs/ATMPs), new indications, variations, and other lifecyle procedures, as well as supporting submissions to other markets in the EMEA region. There is also the opportunity contribute to the development of early phase drugs.

The Candidate

The successful candidate will have good all round general regulatory affairs experience, with a sound understanding of the drug development process, and a detailed knowledge and familiarly of the European and EMEA regulatory framework, including the centralised procedure and clinical trial applications.

The ideal candidate will be flexible in approach, and able to work in a dynamic and fast paced environment. Excellent interpersonal, verbal and written communication skills are essential. The candidate will also require regulatory expertise and problem-solving capabilities that will enable successful development of regulatory strategies and technical solutions to support the business and keep the company ahead.

The successful candidate will have the ability to work across different businesses and cultures on a worldwide basis to ensure global alignment and compliance with key stakeholders.

The successful candidate will have a life sciences degree and ideally further qualifications together with a number of years’ experience of hands-on European regulatory activities within a pharmaceutical company.

Description

Input in development, post-approval and life cycle management

• Participate in global regulatory team meetings as appropriate
• Advise the regulatory team on applicable regulatory requirements and project specific regulatory issues
• Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.

Liaison with Regulatory Agencies and Local Operating Companies

• Act as back-up for contact with Regulatory Agencies as needed
• Draft cover letters for Regulatory Agency communication
• Assist in the preparation of meetings with Regulatory Agencies
• Liaise with LOCs, ensure responses to queries are made in a timely manner and content is consistent with the regulatory strategy.

Input in document and process development

• Assist in development of processes related to regulatory submissions
• Draft and review some document content (depending on level of regulatory knowledge / expertise)
• Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
• Track dates of submissions and Regulatory Agency responses

Clinical Trial Applications (CTA)

• Review protocols and ensure alignment with regulatory requirements
• Advise team on required documents and submission strategies in preparation of CTAs
• Ensure CTA submission packages are complete and available according to agreed timelines
• Review and approve clinical trial supply plans

Marketing Authorization Applications (MAA)

• Provide regulatory support throughout registration process
• Provide regulatory support throughout life-cycle management
• Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
• Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
• Assist with submission and acceptance of MAA
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans

Qualifications

Qualifications

• A minimum of a University degree – medical or paramedical (pharmacy, biology, veterinary etc.)
• 2-4 years of industry experience; 2+ years of regulatory experience preferred.
• Ability to successfully work within a complex team environment
• Project management skills, excellent oral & written communication skills, organization and multi-tasking skills will be needed.
• Excellent English verbal and written communication skills are required.

Primary Location

United Kingdom-England-High Wycombe-

Other Locations

Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization

Janssen Cilag Ltd. (7360)

Job Function

Regulatory Affairs

Requisition ID

2105992971W

Company: Johnson & Johnson

Vacancy Type:  

Job Location: High Wycombe, England, United Kingdom

Application Deadline: N/A

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