Johnson & Johnson
Regulatory Affairs Manager - Remote
Regulatory Affairs Manager - Remote
UK Applicants ONLY
Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
Janssen-Cilag UK Limited has a vacancy in their Regulatory Affairs Team, located in High Wycombe however you can work 100% for this role.
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. And we pursue the most promising science, wherever it might be found.
At Janssen, our Regulatory Affairs team is dedicated to ensuring that the market authorisations for medicinal products that Janssen places onto the UK and Irish markets are compliant with current EU and national regulations and laws.
This role involves close collaboration with cross-functional teams, keeping them informed of regulatory strategy contributing to launch excellence and effective lifecycle management of products (small molecules, biologicals as well as ATMPs/GMOs). Janssen has a strong portfolio of products, with new MAA's planned in the next five years
Duties and Responsibilities:
- Responsible for specific therapeutic area activities aligned to one or more Core Value Team(s)(CVT's)
- Work within an innovative Regulatory Affairs department, supporting and leading timely submissions, approvals and strategy for earlier access for patients.
- Management of processes to ensure compliance with regulatory requirements and an inspection ready culture
- Post Brexit, assist in timely preparation and submission of regulatory applications for new pipeline products to the MHRA
- Maintain awareness of existing and new legislation/guidance and ensuring that colleagues and the business are aware of any changes and potential impacts
- Contribute to shaping external regulatory environment
- Lead the adoption and implementation of new systems and processes to streamline routine regulatory activities
- Line management of direct reports
Professional Experience Required:
- Significant Regulatory Affairs experience at both operational and strategic level
- Strong data gathering and analytical skills
- Direct experience and strong knowledge of general regulatory requirements and guidelines
- Significant persuading/influencing, negotiating skills
- Line management experience
- University Degree in Pharmacy, Biology, Chemistry or related Life Science
- Fluent in English
- Occasional flexible work hours and reachable in case of emergency
- May be able to explore flexible working pattern
In return for this role you will receive a very competitive hourly rate. A minimum 8 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson.
Things to remember before applying for this role:
- This role is INSIDE IR35. The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
- We are looking to process the first round of applications within the next 2 working days.
- We do not accept applications via email.
- You must be UK based.
If you are interested in this role please apply now! Make sure you fill out your application in full, you’re personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application!
Thank you very much and we look forward to receiving your application.
If you would like some additional information about the role please contact: Tabitha.firstname.lastname@example.org