Global Regulatory Affairs CMC Specialist
Johnson & Johnson
Warsaw, PL
5 d. temu

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

supporting EMEA)

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
  • Qualifications :

  • 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
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