NL - Specialist 3, Regulatory Affairs

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are eager to share an exciting contract opportunity for a Senior Regulatory Affairs Specialist to join our expanding team in Janssen, Leiden. Our ideal candidate will have experience in dossier development, regional applications such as IND/IMPD or MAA/BLA, and RA CMC knowledge.

1. Position Title: Regulatory Affairs Specialist

2. Sector: Janssen Biologics B.V.

3. Location: Leiden, Netherlands

4. Bill Rate: 124.16 EUR

5. Length of the project:

As Senior Regulatory Affairs Specialist, you will be responsible for providing support for the regulatory department to ensure efficient and compliant business processes and environment. You may execute tasks and exercise influence generally at the senior management level.

As a Regulatory Affairs Specialist, your typical day may include:

·       ensuring compliance with regulatory agency regulations and interpretations.

·       preparing responses to regulatory agencies' questions and other correspondence

·       gathering and assembling information necessary for submissions in accordance with regulations and relevant guidelines

·       involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides

·       providing solutions to a variety of problems of moderate scope and complexity

·       organizing and maintaining reporting schedules for new drug application and investigational new drug applications

·       providing the strategy and knowledge needed to ensure that CMC practices are carried out in accordance with the requirements of regulatory bodies

·      assess product design, manufacturing, packaging, sterilization, and labelling changes for compliance with applicable regulations and prepare submissions, as required

·    identification of data requirements (e.g., clinical trials, CMC, stability program, local studies) and dossier/legal certificate requirements

·       interacts and aligns with internal/local business partners (e.g. Medical Affairs, Marketing, New business opportunities, legal, etc) to contribute with product strategy, local registration and launch activities

·       prepare response documents/dossiers in alignment with EMEA Liaison, CMC-RA and/or LOC

EDUCATION AND EXPERIENCE YOU’LL BRING:

Our future colleague MUST-HAVE:

·       Experience in dossier development - Module 3

·       IND/IMPD or MAA/BLA

·       Able to work in a Documentum System

·       Skilled in Word

·       Hands on dossier development experience

·       Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs

·       (RA) guideline knowledge

·       Good communication Skills

·       University/Bachelors Degree or Equivalent

What else you’re great at:

• Think analytically and critically
• Communicate effectively verbally and in writing
• Pay strong attention to detail
• Organize and track complex information
• Communicate with diverse audiences and personnel
• Write and edit technical documents
• Working knowledge of local regulations and guidelines related to drug development and registration
• Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment
• Proficient use of technology including MS office programs and Internet resources