Manager Regulatory Affairs
Company: Johnson & Johnson
Location: San Angelo
Posted on: June 12, 2021
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
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
- Serving as the Regulatory representative on specific
multi-discipline teams, may be responsible for organizing and
- Providing regional input to the global regulatory
- 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
- Providing input to Standard Operating Procedure documents to
ensure accuracy and compliance, as appropriate.
- 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
- 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
- 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
- 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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