Experienced Cross Regional Regulatory Professional

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Job Description:

The Experienced Analyst Regulatory Affairs (P5) provides support to the C-ROSS(MS) Product Leader (CRPL) and Regulatory Regional Leader (RRL) for regulatory activities for products in the assigned portfolio. Key responsibilities include the following:

1. Input in development post-approval and life cycle management

Participates in Working groups to ensure timely regional and local input into product objectives to align regions with CDT/global strategy.

Advises the Regulatory team on applicable regulatory requirements project specific regulatory issues as assigned;

Develops an understanding of the regional regulatory environment competitor intelligence and therapeutic area.

2. Interaction with the Regional groups and Local Operating Companies

Works with the regional staff and LOCs to support regional and local activities;

Assists in the preparation of meetings with Regulatory Agencies.

3. Input in document and process development

Assists in the development of processes related to regulatory submissions;

Drafts and reviews document content (depending on level of regulatory knowledge/expertise);

Provides input to documentation to ensure they are in line with product strategy and thoroughly and accurately answers the questions being posed;

Tracks dates of submissions and Regulatory Agency responses.

4. Marketing Authorization Applications

Provides regulatory support throughout registration process and life-cycle management (e.g. iCTDs ACTDs renewal applications Health Authority Responses site registrations and routine marketed product submissions including PSURs RMPs);

Advises team on required documents in preparation of submissions as assigned;

Assists with timely registration dossier availability ensures that all document components are in place on time identifies and tracks critical path activities;

Compiles Module 1 for iCTDs to be dispatched to countries;

Manages and tracks the assembly of country-specific submission packages to the LOCs in accordance with agreed plans.

5. General

Responsible for the critical review of submission documents to ensure compliance with regulatory requirements;

Provides regulatory support for and appropriate follow-up to inspections audits litigation support and product complaints (depending on level of regulatory knowledge/expertise);

Serves as the Regulatory representative on specific multi-discipline teams;

Keeps abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws guidance and requirements related to those areas.

Principle responsibilities for the Regulatory Scientist include:

Supports all regulatory activities associated with the development post-approval and life-cycle management for designated products. Provides regulatory support for products by interacting with project teams LOCs and regional teams for registration dossier related submissions as appropriate.

Provides other general support on an as-needed basis e.g. provides regulatory input and follow-up for inspections audits litigation support and products complaints (as appropriate)

Participates in the development of departmental processes and procedures.

Required Leadership Competencies:

Results & Performance Driven (GLP): Assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations; makes the customer central to all thinking; keeps the focus on driving customer value

Analytical Thinking: Understanding a situation by breaking it apart into smaller pieces or tracing the implications of a situation in a step-by-step way. Analytical Thinking includes organizing the parts of a problem situation a systematic way; making systematic comparisons of different features or aspects; or systematically breaking down multidimensional complex problems or processes into component parts and using several analytical techniques to assess several solutions and weigh the value of each

Communication: The ability and intent to effectively explain describe or convey information orally or in writing to individuals and to a wide variety of large and small groups. Includes speaking with authority confidence and conviction. Also includes using visual aids e.g. charts graphs effectively and responding effectively to questions

Concern for Quality and Order: An underlying drive to reduce uncertainty in the surrounding environment. It is expressed in such forms as monitoring and checking work or information insisting on clarity of roles and functions and putting systems and processes in place to meet information needs

Self Awareness & Adaptability (GLP): Resilient; has personal modesty and humility; willing to learn from others; patient optimistic flexible and adaptable

Intellectual Curiosity (GLP): Sees the possibilities; willing to experiment; cultivates new ideas; comfortable with ambiguity and uncertainty

Sense of Urgency (GLP): Proactively senses and responds to problems and opportunities; works to reduce cycle time; takes action when needed

Collaboration & Teaming (GLP): Puts interests of enterprise above own; works well across functions and groups; builds team effectively; inspires followership; instills a global mindset; champions best practices

Required Technical Competencies & Knowledge:

Technical competencies will vary depending on level

Submissions

• Knowledge of regulatory requirements related to submissions and of filing registration process.

• Understands CTA iCTD and ACTD dossier component requirements

• Ability to review and contribute to the compilation of CTA iCTD and ACTD dossier components

• Understands submission requirements for lifecycle submissions e.g. protocol amendments post-approval variations annual reports PSURs DSURs RMPs renewal applications

• Knowledge of Microsoft programs as well as electronic management systems (e.g. RIMDocs GRAIL)
  
  

Regulatory Intelligence

• Awareness of competitive landscape e.g. views of HA regulatory precedence labeling differences and product related issues

• Up-to-date knowledge of current and pending approvals of competitor products

• General knowledge of laws guidance and requirements and their implications related to specific therapeutic areas/product

• Basic understanding of scientific and medical principles application to specific products.

Regional Regulatory Strategy Implementation

• Understands life cycle of drug product from discovery through marketing and post-approval requirements

• Ability to interpret and apply local regulations and guidance to the life cycle of a drug product

• Basic understanding of clinical trials and drug development
  
  

Health Authority Expertise

• Basic knowledge of how Health Authorities operate

• General knowledge of HA organizational structure and individual responsibilities in those structures

General knowledge of HA timelines for reviewing submissions

Educational Background & Knowledge

B.A./B.S. in science/relevant health-related discipline required

Senior Associate: 2 years relevant experience

Basic understanding of regulations and guidelines related to drug development and registration.

Demonstrated ability to handle multiple projects.

Excellent English verbal and written communication skills

Required Skills:

Preferred Skills: