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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Mexico City, Mexico, São Paulo, Brazil

Job Description:

The Senior Analyst, Regulatory Affairs (P6) 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, etc., in 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

 

Mandatory Requirements

- Fluent english (writting and verbal)

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

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking