Senior Associate, Global Submission Management - International

The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions.

Roles & Responsibilities:

• Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans.
• Participation in information system and software update projects as well as ongoing system validations
• Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM.
• Independently remain current on guidance (internal/external) and translate requirements into operational activities.
• Represent departmental expertise on regulatory projects and regional/global workstreams.
• Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
• Contribute to the development of the strategy for communicating with global health authorities
• Initiate, lead and manage process development and improvement
• Participation in information system and software update projects as well as ongoing system validations

Required Knowledge and Skills:

• Advanced technical and project management skills, demonstrated experience working in and leading teams

• Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc.

• Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards

• Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used

• Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred)

Preferred Knowledge and Skills:

• Advanced knowledge of Veeva Vault RIM,

• Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications

• Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans.

Basic Education and Experience:

• Master’s degree and 3-4 years of directly related experience

OR

• Bachelor’s degree and 4-6 years of directly related experience

OR

• Associate’s degree and 6-8 years of directly related experience

OR

• High school diploma / GED and 8+ years of directly related experience

Preferred Education and Experience:

Practical experience with submission requirements for EU, JAPAC, GCC, ZA