Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is looking for a Senior Specialist, Global Regulatory Affairs CMC.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees.
The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide.
Our portfolio ranges across several distinct business units : Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products.
GLOBAL REGULATORY AFFAIRS CMC SPECIALIST
Location : Warsaw, Poland
The Specialist, Global Regulatory Affairs-CMC works semi-autonomously and has responsibility for a portfolio of products, supporting a significant area of the business or function.
This is a global role with a primary focus on support to R&D and maintenance activities based in the EMEA Region. Under the supervision of Global CMC leadership and as a representative of the Global Regulatory Affairs (GRA) CMC organization.
Responsibilities Include :
Partner with R&D, QA, Operations, Business Units and others to contribute to regulatory CMC strategies for submissions and product related activities.
Identify the required documentation for CMC submissions and negotiate the delivery of approved technical source data and documents in accordance with project timelines.
Write or compile high-quality CMC documents during development and product registration, contribute to CMC regulatory strategies, assure technical congruency and regulatory compliance by meeting agreed submission deadlines.
Review post-approval changes (change controls) and assess the regulatory impact on affected registrations. Contribute to regulatory strategies and coordinate filings (e.
g. NDA supplements, Variations and Renewals), as appropriate.
Compile responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines.
Communicate information and present status updates on product / project activities to key internal / external stakeholders of various levels.
May represent J&J and provide regulatory advice at e.g. joint company / trade association initiatives, regulatory agency meetings etc.
as appropriate), seminars, workshops, etc.
Assists in development of best practices for Regulatory Affairs processes.
Maintains and archives regulatory documentation (as appropriate).
Coordinates small work groups and participates on providing direction.
Applies organizational understanding and awareness and participates in decision making in collaboration with others.
Uses effective communication and employs influencing skills to establish key relationships with internal / external contacts.
Keep knowledge up to date regarding quality guidelines and technical trends.
Work collaboratively with global CMC colleagues and provide support, as required
A Minimum of a B.S. in relevant technical or scientific field is required.
A minimum of 3 years relevant CMC experience including preparation of CMC sections for Health Authority filings (Modules 2 and 3, CTD, e-
CTD) and maintenance. Experience with global regulatory filings is beneficial.
Working knowledge of regulatory requirements for various drug dosage forms including solids, semi-solids and solutions is required.
Familiarity with consumer product categories (drugs, cosmetics or devices).
Experience with devices and combination products may be beneficial.
Experience with EMEA submissions is strongly preferred. Experience with US, and Canadian submissions is beneficial.
Technical / science-based background (QA, Manufacturing, Laboratory, Plant, etc.) is preferred.
This position will require
We offer :
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
Motivating financial remuneration
Other employee benefits