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.

Assistant Director Global Regulatory Strategy

Your tasks and responsibilities

The primary responsibilities of this role, Assistant Director Global Regulatory Strategy, are to: 

 

  • Contributes to the development of local regulatory project goals from development through life cycle;
  • Participates in the preparations for meetings and teleconferences with local HA officials;
  • Works with Lead GRS and supervisor to compile and submit IND and clinical trial applications to enable timely start of the clinical trials for the assigned development products;
  • Works with Lead GRS and supervisor to develop submission materials for local HA, guides the review process, checks for accuracy, scientific consistency, compliance to local HA regulations and completeness of submission;
  • Collects, reviews and analyzes competitor information, local Agency guidelines and precedence Keeps abreast of changes in the local regulatory environment for the project;
  • Contributes to the development of the Briefing document for the local authority meeting for assigned projects;
  • Responsible for entering submission material and other documents and relevant data into appropriate RA databases;
  • Where applicable, reviews external and internal communications on local level for regulatory accuracy and local HA compliance;
  • May act as the primary interface between Bayer and the local Health Authority (HA);
  • May be involved in decision making on key development questions;
  • May participate in ad hoc Global Project Team sub-teams or working groups as invited by the Global Project Team;
  • May participate in a global regulatory team (GRT) and provided local regulatory input into the global development plan for assigned projects;
  • Incumbent must use knowledge and past experience to be responsible for the review of submissions to Regional HA to assure Regulatory Compliance.
     

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., D.V.M. or Pharm.D.) in life sciences with 2 years direct experience in biomedical research activities; or MS with 4 years of experience in biomedical activities; or BS with 6 years of experience in biomedical activities;
  • Basic knowledge of local Health Authority (HA) regulations (FDA or EMA) to support filings;
  • Basic understanding of drug development (PK, PD, statistical concepts, data collection, endpoints, etc.);
  • Good communication skills, verbal and written;
  • Ability to work within a global team framework;
  • Strong analytical skills;
  • A thorough knowledge of policies and procedures in drug development and product maintenance requirements;
  • May have the ability to organize and direct diverse activities in a changing environment often under time pressure;
  • Demonstrated problem solving skills as applied to local regulatory issues.

 

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