Senior Associate Regulatory Affairs - Marketed Product Support in Bernards, NJ at DSI

Date Posted: 8/12/2017

Job Snapshot

Job Description

IMPORTANT NOTE: We are very pleased to announce the location of Daiichi Sankyo, Inc.’s new US headquarters where our Parsippany- and Edison-based teams will be co-located in a combined site in early to mid-2017. Our new headquarters will be in Basking Ridge, New Jersey at 211 Mt. Airy Road.

Job Summary

Provide operational regulatory support for assigned marketed products and regulatory oversight and compliance in DSI territories in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards. Act as a specialist with regard to specific fields of regulatory or therapeutic knowledge. Representing West RA in internal and external interactions (e.g. project teams, working teams, authorities, affiliates, license partners).

Responsibilities

1. Provide operational support for regulatory submissions and activities in a timely and accurate manner in US and ex-US countries. This includes:
  • Prepare/support regulatory documents and registration dossiers for assigned marketed products (e.g. sNDAs, annual reports, responses to authority requests and any other regulatory submission) to agencies (FDA and other).
  • Closely cooperate with the assigned regulatory strategist and the product team.
  • Review regulatory documents and registration dossiers.
  • Monitor and track submissions and deadlines.
  • Respond to general internal and external inquiries including operational queries from agencies.
  • Support archiving of regulatory files.
  • Support organisation of agency meetings.
2. Act as primary contact for DSI affiliates and license partners for queries, requests, coordination and tracking of dossier preparation and regulatory submissions (incl. timelines) for assigned products.
3. Collaborate with other functions within DSI, DSE and DS Japan, e. g. Production, Quality Control, Clinical Safety and Pharmacovigilance, Marketing, Medical, Clinical Operations, with DSI affiliates and external partners in order to maintain existing marketing authorisations and support for new product registrations.
4. Initiate and/or coordinate the preparation of packaging materials, including QC check of specific packaging material and monitoring of implementation of new packaging material.
5. Manage entries to internal and external databases, registries and listings, maintain team sites on collaboration platforms (e.g. SharePoint) by providing up-to-date regulatory information and documents in a timely manner.
6. Support budget preparation, invoicing, accounting and procurement processes and provide general administrative support when required.

Qualifications

Education
  • Bachelor’s degree
Experience
  • 4-5+ years of relevant work experience in a Regulatory Affairs or Clinical Research organization within pharmaceutical, biotech, medical device company with emphasis on Life-Cycle Management and maintenance of US and ex-US licenses.
  • Experience working in a global, international regulatory environment.
  • Understanding of regulatory processes. Ability to plan, coordinate and lead activities simultaneously on multiple projects.
Competencies

Team oriented and forward thinking attitude, strong interpersonal and communication skills,
structured, independent work style, proficient in MS office, superior written and verbal communication skills; second language proficiency (e.g. French, Spanish, Portuguese, German, Japanese) is a plus.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.