Johnson & Johnson Careers

Regulatory Affairs Associate

High Wycombe, United Kingdom
Regulatory Affairs


Job Description

Requisition ID: 1905736389W

Are you a Regulatory affairs associate? Do you have extensive experience in post- approval and life cycle management (LFC), working with Regulatory agencies as well as local Operating companies, Clinical Trial Applications (CTA’s) and Marketing authorization applications (MMA) within the EMEA region?


ROLE DUTIES:

- Advising the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned

- Developing an understanding of the regional regulatory environment, competitor intelligence and therapeutic area

- Acting as back-up for contact, drafting cover letters and assisting in the preparation for meetings with RA.

- Liaise with LOCs, track and respond to queries in a timely manner

- Assist in development and improving processes related to regulatory submissions

- Drafting and reviewing document content (depending on level of regulatory knowledge / expertise)

- Providing input to documentation to ensure they accurately answer posted questions.

- Track dates of submissions and Regulatory Agency responses

- Reviewing protocols and ensure alignment with regulatory requirements

- Advising the team on team submission strategies in preparation of CTAs and ensuring completion of submission packages within agreed timelines.

- Reviewing improving and approving clinical trial supply plans

- Provide regulatory support throughout registration process, and lifecycle management

- Assisting with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities

- Assisting with submission and acceptance of MAA

- Ensuring country-specific submission packages are made available to the LOCs in accordance with agreed plans

Qualifications
ESSENTIAL EXPERIENCE SKILLS AND EDUCATION:

- You have University degree in related field (Medical, Paramedical, Scientific)

- 3 year + experience in Regulatory Affairs

- You are a keen Project manager with extensive experience

- You have experience of submitting CTA’s.

- You have a background in providing regulatory support through the MMA Registration process and through lifecycle management.

- You have are a committed regulatory professional with a keen eye for detail

- You are an excellent communicator and with phenomenal interpersonal skill

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.


Primary Location
United Kingdom-England-High Wycombe-
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
1905736389W