Johnson & Johnson Careers
Global Regulatory Affairs CMC Specialist
Requisition ID: 1805673068W
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.
- 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 <10% domestic/international travel.
- 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
Johnson & Johnson (Poland) Sp. z.o.o. (7815)