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Global Regulatory Affairs Leader

  • Bayer
  • Whippany, NJ 07981
  • Full-Time



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We pride ourselves in being research-driven, with businesses in CropScience and HealthCare. We are also proud of our environmental record, our safety performance, and our manufacturing expertise. You can only imagine our pride at being named one of Fortune magazine's most admired companies.



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Without the dedicated people who work in our labs, offices and manufacturing facilities as well as in the field, we would never have given the world the variety of Bayer discoveries that bring quality to daily life. Our people remain our most valuable asset, and we provide the ongoing training and development they need to remain at the top of their respective fields.



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Bayer offers employment opportunities at all levels throughout the United States and globally. Recruitment at Bayer occurs continuously as new jobs become available. Therefore, we encourage you to review our website to get a feel for who we are, the type of work we do, our mission and values, and our employees.



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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life.






At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.



Apply online





Global Regulatory Affairs Leader



Your tasks and responsibilities



The primary responsibilities of this role, Global
Regulatory Affairs Leader, are to:









+ Has accountability for developing
robust Global Regulatory Strategy for complex/high impact programs
in the Oncology portfolio that leverages accelerated regulatory
approval pathways and other innovative strategies that enable
fastest path to first cycle
approval;



+ Provides guidance and oversight to
Global Regulatory Strategists on assigned program that have
regional and/or local responsibility to ensure integration of
regional/local requirements into the overall Global Regulatory
Strategy;



+ Serves as the Global Regulatory Expert
for the assigned program and partners effectively with the Global
Development Leader (GDL)/Early Development Portfolio Lead (EDPL),
Global Clinical Leader (GCL)/Early Clinical Leader (ECL), Global
Project Leader (GPL)/Early Project Leader (EPL) and the Biomarker
Leader to develop strategy documents to support decision making at
Governance committees and for formal meetings with Health
Authorities;



+ By leveraging technical expertise
relevant to the assigned complex program that has high impact on
Oncology portfolio, this position
will



+ have serve as the Regulatory Strategy
expert on the Global Product Team
(GPT);



+ Integrating the local/regional
regulatory requirements into the best and single global regulatory
strategy requires broad global experience and efficient interaction
with many multinational and multifunctional
partners;



+ The best global regulatory strategy is
important in achieving early approvals with competitive labeling.
The assessment on the probability of regulatory success has a major
impact on the overall Probability of Technical Success (PTS) for a
development project and thereby on the prioritization and
commercial value of the project.

















Who you are







Your success will be driven by your demonstration of
our LIFE values. More specifically related to this position,
Bayer seeks an incumbent who possesses the
following:







Required Qualifications:









+ Advanced technical degree Ph.D., DVM or
Pharm D in life sciences preferred 8 years in medical research
activities of which 3-5 years include local/ global regulatory
experience in related TA area, or MS degree with 10 years of
medical research activities of which 5-7 years include local/global
regulatory experience in related TA area, or BS degree with 12+
years of medical research activities of which 10-12 years include
local/global regulatory experience in related TA
area;



+ Expert knowledge of the regional and
global regulations;



+ Demonstrated interactions with local
and global health authorities;



+ Excellent communication skills, verbal
and written, and strong analytical skills are
required;



+ Demonstrated leadership and project
management skills, including cross-functional communication,
interpersonal and influence-management
skills;



+ A clear understanding of cultural and
business needs in leading a diverse
team.









Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the \"Passion to Innovate\" and the \"Power to Change\", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.













Bayer is an Equal Opportunity Employer/Disabled/Veterans







Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

















Country:United States

Location:NJ-Whippany

Functional Area:[sap_fa_32]

Entry Level:5
Associated topics: .net, application architect, application developer, c, c#, design, lead, project architect, senior, software engineer lead




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