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Manager Regulatory Affairs

Company: Johnson & Johnson
Location: San Angelo
Posted on: June 12, 2021

Job Description:

Janssen a member of Johnson & Johnson's Family of Companies, develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in pulmonary hypertension, oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit

We are currently recruiting a Manager Regulatory Affairs (NA Regulatory Scientist) for our Global Regulatory Affairs organization. The position is preferably based inRaritan NJ (USA) or Titusville NJ (USA), but other locations could also be considered.

As Manager Regulatory Affairs (NA Regulatory Scientist), you will under the direction of the NARL/GRL, be responsible for

  • Preparing IND, CTA, NDA and eCTD dossier filings and related submissions, including preparation of meeting packages and responses to Health Authority (HA) inquiries as delegated by the NARL or GRL.
  • Maintaining working knowledge of local regulations and submission requirements for lifecycle submissions, e.g., protocols and protocol amendments, informational amendments, annual reports, IND Safety Reports, PADERs and PSURs.
  • Performing critical review of submission documents to ensure compliance with regulatory requirements. May provide regulatory input for and appropriate follow-up to inspections, audits and product complaints.
  • Serving as the Regulatory representative on specific multi-discipline teams, may be responsible for organizing and leading meetings.
  • Providing regional input to the global regulatory strategy.
  • Assisting in strategy development by researching regulatory and medical information in preparing submissions to regional HAs.
  • Reviewing and interpreting related product approval information and current HA guidances and Advisory Committee meetings.
  • Partner with the NARL/GRL to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and oncology-specific issues.
  • Staying ahead of current and pending immunology approvals and maintain working knowledge of laws, guidances and requirements related to oncology, in addition to general regulatory knowledge.
  • Providing input to Standard Operating Procedure documents to ensure accuracy and compliance, as appropriate.

  • Qualifications
  • A Bachelor's degree and at least 8 years of health regulated industry experience, or a Masters degree and a minimum of 6 years of health regulated industry experience or a PhD/PharmD with a minimum of 4 years of health regulated experience.
  • At least 4 years of relevant regulatory affairs experience in pharmaceutical/biotech or medical device or consumer OTC industry is required.
  • An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
  • Knowledge of HA organizational structure and HA processes for reviewing submissions is required
  • Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
  • Ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development is beneficial
  • Solid understanding of biology and chemistry relevant to therapeutic area is preferred;
  • Diverse therapeutic area experience (e.g. oncology, immunology, vaccines, gene therapy etc.) would be beneficial
  • Experience with rare disease or orphan disease indications would be beneficial
  • A previous track record of success working successfully within a cross functional team environment as an individual contributor and decision maker within a cross-functional organization is required
  • A previous track record of success of effectively prioritizing assignments for multiple projects simultaneously is required.
  • 10% domestic travel and potential international travel may be required for this position.

Diversity and inclusion are at our core. Theyve been part of how weve worked since our foundation over 130 years ago, and our commitment to respect your diversity is enshrined in our Credo. We are nothing without your unique perspective, and our work is about you, your colleagues, and the world we care for, coming together. To achieve this, we create a deep sense of belonging a culture where you are valued, and your ideas are heard. In turn, you advance this culture for everyone. Diversity and inclusion at Johnson & Johnson means: You Belong.

Keywords: Johnson & Johnson, San Angelo , Manager Regulatory Affairs, Other , San Angelo, Texas

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