Global Regulatory Affairs CMC Specialist

Job description

Job Description

Requisition ID: 1905720435W

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 LCM activities based in the EMEA Region. Under the supervision of LCM and CMC leadership and as a representative of the Global Regulatory Affairs (GRA) organization.

Responsibilities Include:

·  Partner with R&D, QA, Global Technical 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 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 #CoBIC

Desired profile

Qualifications

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 Canadiansubmissions is beneficial.
·  Technical/science-based background (QA, Manufacturing, Laboratory, Plant, etc.) is preferred.
·  Fluent English language
Primary Location
Poland-Mazowieckie-Warsaw-
Organization
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
Regulatory Affairs
Requisition ID
1905720435W