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.
Asst Dir Gbl Reg Strategy
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Assistant Director Global Regulatory Strategy, are to:
- Contribute to the development of local regulatory project goals from development through life cycle;
- Participate in the preparations for meetings and teleconferences with local HA officials;
- Work 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;
- Work 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;
- Collect, review and analyze competitor information, local Agency guidelines and precedence Keeps abreast of changes in the local regulatory environment for the project;
- Contribute to the development of the Briefing document for the local authority meeting for assigned projects;
- Be responsible for entering submission material and other documents and relevant data into appropriate RA databases;
- Review external and internal communications on local level for regulatory accuracy and local HA compliance;
- Act as the primary interface between Bayer and the local Health Authority (HA);
- Be involved in decision making on key development questions;
- Participate in ad hoc Global Project Team sub teams or working groups as invited by the Global Project Team;
- Participate in a global regulatory team (GRT) and provided local regulatory input into the global development plan for assigned projects;
- Use knowledge and past experience and 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:
- Bachelor of Science with at least six years of experience in biomedical activities or Master of Science with at least four years of experience in biomedical activities or Advanced technical degree (Ph.D., D.V.M. or Pharm.D. in life sciences with at least two years direct experience in biomedical research 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 company policies and procedures in drug development and product maintenance requirements;
- 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.
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. 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.
IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer active employees are required to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status before participating in approved activities for fully vaccinated employees. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, if candidates are invited on site as visitors for in person interviews, they must provide proof of being vaccinated and comply with all safety protocols.
State: New Jersey
Reference Code: 520681
Functional Area: Regulatory Affairs
Entry Level : Professional