The Johnson & Johnson Group of Consumer Companies is recognized as a world leader in providing health and beauty products and solutions across Baby, Beauty, Healthcare and OTC medicines. The breadth and depth of our product portfolio is truly impressive and constantly expanding as we strive to bring science to the art of healthy living.
GLOBAL & EMEA REGULATORY AFFAIRS SPECIALIST CMC
The responsibilities & the impact YOU will have:
Developing RA CMC strategy for life-cycle management activities for chemical related medicinal products and being a partner to R&D, QA, Operations, Business Units.
Identifying the required documentation for CMC submissions (gap analysis) and adjusting Module 3 according to current submission purposes.
Writing high-quality CMC dossier during development and product registration, including justifications, statements and other CMC-related documents based on technical justifications.
Contributing to CMC regulatory strategies, assuring technical congruency and regulatory compliance by meeting agreed submission deadlines.
Reviewing post-approval changes and assessing the regulatory impact on affected registrations.
Preparing responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines.
Representing the Applicant and providing regulatory advice at e.g. joint company initiatives, team meetings, seminars, etc.
Assisting in development of best practices for Regulatory Affairs processes.
Applying organizational understanding and awareness and participate in decision making in collaboration with others.
Using effective communication and employing essential skills to establish key relationships with internal/external contacts.
Keeping knowledge up to date regarding quality guidelines and technical trends.
Working collaboratively with globally located RA colleagues and provide support, as required.
A minimum of a B.S. in relevant technical or scientific field (chemistry, pharmacy, biotechnology) is required.
A minimum of 4 years relevant CMC experience including preparation of CMC sections for Health Authority filings (Modules 2 and 3, CTD, e-CTD) and maintenance and experience with global regulatory filings is required.
Working knowledge of regulatory requirements for various drug dosage forms.
Experience with EMEA submissions is required; and US, Canada is preferred.
Technical/science-based background (Health Authority, QA/QC, Manufacturing site, Laboratory) is preferred.
Fluent English in writing and speaking is required.
This is what awaits YOU at J&J:
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
Many opportunities to work on challenging projects and assignments.
Possibilities for further personal as well as professional development.
- Many employee benefits.
Johnson & Johnson (Poland) Sp. z.o.o. (7815)