Your tasks and responsibilities
The primary responsibilities of this role, Global Submission Specialist, are to:
Who you are
- serve as the global specialist responsible for planning, coordinating and conducting the electronic and hard-copy international technical document preparation and submission procedures for regulatory approval of our pharmaceutical products.
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:
- must have a bachelor's degree (or foreign equivalent) in Chemical Engineering, Regulatory Science or related field;
- five (5) years of post-baccalaureate and progressively responsible experience in a related position;
- interacting with the FDA inclusive of pre- and post- approval regulatory matters;
- IND, NDA, and BLA drug development inclusive of applicable health authority and ICH requirements;
- FDA post-approval change requirements (21 CFR 314.70);
- preparing and maintaining U.S. DMF submissions and amendments;
- s ubmission planning on both electronic and paper submissions with various complexities sent to international health authorities, across all phases of a product lifecycle including PBRER, CSR, MAA, CTA, IMPD, etc.;
- eCTD 4.0 and RPS as well as eCTD version upgrade and implementation;
- GxP relevant computerized systems testing and problem-solving for electronic submission publishing, review, validation and archiving, in accordance with the GxP relevant Quality Assurance procedures;
- conducting training for internal cross-functional professional staff, on document authoring, document management systems, and international workflow processes; and
- developing and maintaining operational guidelines and best practices in accordance with various health authority regulations and global standard operating procedures.
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:
A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.