Regulatory Affairs Executive

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Purpose of the role

We are seeking an assertive and confident Regulatory Affairs Executive to join our UK RA Team. The successful candidate will be responsible for helping establish and implement cost effective, results based, and professionally managed programs and innovative initiatives for the organization to advance business initiatives. Contributes to projects, programs or processes for the business area. You will also be responsible for integrating methods based on analyses of trends in the product lifecycle for marketing applications and supplements. Conducting sophisticated research related to labelling precedent, regulations, policies, and other topics as necessary to accurately advise on potential labelling impacts, strategies, or outcomes. As a more senior member of the team, you will be encouraged to mentor more junior colleagues in all aspects of the role and demonstrate the J&J Credo and Leadership Imperatives in day-to-day interactions with the team.

Summary of responsibilities

• Management of the regulatory activities in line with the existing processes to ensure compliance with regulatory requirements and an inspection ready culture.
• Develop or contribute to local regulatory strategy in line with the applicable Regulatory requirements.
• Responsible for specific therapeutic area activities, including but not limited to handling the Agency submissions and questions, including cross-functional team attendance as required.
• Cross portfolio technical and administrative activities as required.

Key role activities:

• Partner with Reg Manager and allocated cross-functional team to provide RA strategic and technical expertise and support for submissions and HA interactions.
• Prepare and submit new MAA, ILAP IP, TDP and UK PIPs and other local submissions as assigned.
• Review and approve regulatory variation documentation.
• Monitor deadlines for different projects to ensure they are met or escalated to a Regulatory Affairs manager and/or Head of RA.
• Responsible for the content of the local labelling documents released to prescribers and patients.
• Prepare and distribute local labelling documents within stipulated timelines following receipt of relevant approvals.
• Implement Risk Management Plans and when required co-ordinate a cross-functional team to implement/update Risk Management Educational Material.
• Deputises for Regulatory Affairs Manager when required.

Compliance

• Complete activities to ensure compliance with all regulatory requirements.
• Develops and maintain in depth knowledge of regulations/legislation.
• Supports with collection of RA competitive intelligence as required.
• Subject matter expert on given topic and author of relevant SOPs, assuring timely execution and compliance.

Internal/External contacts

• Support other departments based on their needs by providing documentation and information in response to requests.
• Proactively share key regulatory insights with business to help shape brand strategy.
• Contact local Health Authorities to resolve general queries (some product specific) when these cannot be addressed internally ensuring a positive interaction in any communication.

Miscellaneous

• Undertake, support and contribute to initiatives as requested by Head of RA.
• Contribute to initiatives around lessons learnt and change management to ensure efficiency gains.
• Actively contribute to growing the regulatory expertise of the team by mentoring of junior regulatory colleagues.

By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

What’s in it for you?

It’s important to us that you feel you can bring your whole self to work; at Johnson & Johnson we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. As part of our offering, you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme.

Required Skills: Licensing Compliance, Pharmaceutical Regulatory Affairs, Regulatory Affairs Compliance

Preferred Skills: Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking