Manager EMEA Regulatory Affairs Self Care

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.

With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world.

At Johnson & Johnson Consumer, we have a truly outstanding brand portfolio, with power brands across multiple categories, including Neutrogena, Natusan, Piz Buin, o.b, Imodium, Tylenol, and Nicorette.

Within Self Care we innovate and deliver new non-prescription (OTC) medicines and solutions within the following six Need States: Pain, Allergy, Eye care, Smoking Cessation, Digestive Health and Cough & Cold. There are two R&D centers of excellence for Self-Care, one of them is in Helsingborg, Sweden (the other one is in the US). The UK offices in Maidenhead and High Wycombe host additional Regulatory and Medical colleagues within the Self Care R&D organization.

The Global and Regional Regulatory team supports the Europe, Middle East and Africa (EMEA) region and is made up of nine colleagues from both Sweden and the UK. The team supports product development across all six Self Care Need states and maintains the existing product portfolio across all markets in the region through regulatory life cycle management. We are looking for an individual who will be a part of the team providing global and regional EMEA support to the Self Care Need States!
You will report to the Associate Director, Global & EMEA Self Care, and act as the global regulatory lead (GRL) on new product development projects and provide lifecycle management support.

Responsibilities
You will be participating in cross-functional project teams as GRL and help deliver key initiatives across the Self Care product portfolio. Working with local and regional Reg colleagues to develop regulatory strategies, coordinating regulatory actions and deliverables and develop global/regional dossiers and support local review processes.
You will lead non-CMC product lifecycle management such as labelling and variation submissions for EMEA Self Care products registered through MRP or DCP procedures.
We need someone to provide regulatory support to policy, external engagement, and issue management. You may also provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties.
The role needs someone who excels at collaboration and coordination and with effective communication and influencing skills to continue to grow key relationships with internal and external contacts.



Qualifications
A detailed understanding and 2+ years’ experience of the development and support of OTC medicines is highly recommended.
A science degree with proven track record and an understanding of regulatory strategy in the pharmaceutical, consumer, or medical devices sector. (BSc required; MSc preferred)
Experience of global and regional regulatory strategy development within the OTC area is preferred.
Experience in interacting with EMEA regulatory authorities will be helpful.
Experience in a cross-functional team environment with project management exposure preferred.