Regulatory Labeling & Compliance Specialist

We, at Janssen Egypt, are ‎150+ passionate employees working tirelessly to make
the world a better place and to treat, cure, stop, and prevent some of the
most devastating and complex diseases of our time -- from immune-mediated
diseases and cancers to mood disorders, pulmonary arterial hypertension, and
HIV. At Janssen, we never stop working toward a future where the disease is a
thing of the past. We're the Pharmaceutical Company of Johnson & Johnson, and
you can count on us to keep working tirelessly to make that future a reality
for patients, by fighting sickness with science, improving access with
ingenuity, and healing hopelessness with heart. We are Janssen. We collaborate
with the world for the health of everyone in it. Visit us:
http://www.janssen.com/emea/

Key Responsibilities

• Perform labeling and artwork activities: create and update labeling documents, annotate artworks, perform proofreading, coordinate labeling submission, and implementation, follow up on approvals and implementation internally with all involved functions, and coordinate with the supply chain implementation.


• Participate and lead process improvements initiatives by reviewing current processes and assessing the team's needs


• Create new procedures to standardize the regulatory affairs activities


• Monitor RA activities from a compliance perspective by sending newsletters, and setting critical metrics.


• Support RA activities and projects as needed such as track & trace, RFT, archiving, and eCTD baseline.


• Coordinate RA labeling & compliance projects with the RA team and other functions as needed


• Support the compliance initiatives, gap analysis and quality investigation and set remediation activities, change controls, and audit readiness


• Build tools to monitor Compliance and maintain them


• Update local trackers and systems as needed


• Participate in lifecycle management activities as needed


• Support RA activities and projects as needed

Qualifications

In order to qualify for this role, we are looking for candidates with
minimally a Science-related Bachelor's degree combined with ‎2+ years of
experience in Regulatory Affairs in a multinational pharmaceutical company.
Proficiency in English, as well as Arabic, is vital.

Technical/Functional Skills Required

• Motivated and enthusiastic with a positive mindset


• Precision and accuracy in task execution


• Assiduity and hard working


• Microsoft Office proficiency, especially in Excel, is necessary

Leadership Profile Required

• LIVE OUR CREDO: Demonstrate and inspire the behaviors that reinforce our Credo


• CONNECT: Develop deep insights into the needs of our patients, customers, markets, and communities


• SHAPE: Drive innovation, anticipate and shape industry and market changes to advance health care globally


• LEAD: Build an environment where leadership and talent development are a top priority


• DELIVER: Deliver results by encouraging and mobilizing people and teams
  Johnson & Johnson Family of Companies are equal opportunity employers, and all
  qualified applicants will receive consideration for employment without regard
  to race, color, religion, sex, sexual orientation, gender identity, genetic
  information, national origin, protected veteran status, disability status, or
  any other characteristic protected by law.
  We will ensure that individuals with disabilities are provided reasonable
  accommodation to participate in the job application or interview process,
  perform essential job functions, and receive other benefits and privileges of
  employment. Please contact us to request accommodation.