Senior Regulatory Affairs Associate-00000LA5
Description
Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson (J&J). Please visit http://www.janssen.co.uk/ for more information.
Position Title: Regulatory Affairs Associate
Location: UK , High Wycombe
What type of mark will you make?
Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world.
Key responsibilities:
1. 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, project specific regulatory issues as assigned
- Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
2. 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, track and respond to queries in a timely manner
3. 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
4. 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
5. 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
Education and experience
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Experience in regulatory affairs
- Teamwork experience
Skills
- Project management skills
- Oral & written communication skills
- Organization & multi-tasking skills
Knowledge
- Knowledge of the regulatory environment, guidelines and practice of EMEA regions
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: Regulatory Affairs
Description
Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson (J&J). Please visit http://www.janssen.co.uk/ for more information.
Position Title: Regulatory Affairs Associate
Location: UK , High Wycombe
What type of mark will you make?
Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world.
Key responsibilities:
1. 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, project specific regulatory issues as assigned
- Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
2. 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, track and respond to queries in a timely manner
3. 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
4. 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
5. 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
Education and experience
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Experience in regulatory affairs
- Teamwork experience
Skills
- Project management skills
- Oral & written communication skills
- Organization & multi-tasking skills
Knowledge
- Knowledge of the regulatory environment, guidelines and practice of EMEA regions
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: Regulatory Affairs