Astellas Pharma CMC Regulatory Affairs Manager in Northbrook, Illinois
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose & Scope:
Due to changes in the environment in the pharmaceutical industry, CMC fields of regulatory affairs are becoming more important. There is a need in this field for capability to understand the characteristics of multiple modalities of drugs and the latest regulatory requirements, to realize expedite submission and approval globally with optimal regulatory strategies, and to efficiently maintain the products on the market in post approval stage. We are recruiting a new member who works with us in this field and contribute to bringing our products to patients all over the world.
Essential Job Responsibilities:
Responsible for overall CMC regulatory activities throughout development, NDA and post approval CMC change globally, mainly for biologics.
Establishing CMC regulatory strategy for regulatory submissions.
Communication and collaboration with relevant departments for preparation of CMC sections of regulatory dossier, and the document review.
Coordination of cross functional discussion for CMC section of regulatory dossier.
Maintenance of CMC approval contents globally.
Dealing with information request from HAs and other CMC issues.
The Manager of Regulatory Affairs will report to the Associate Director of Regulatory Affairs CMC who reports to the Senior Director of Regulatory Affairs, a direct report of the Vice President of
BS in Biochemistry/Chemistry/Pharmaceutics or equivalent degree
6+ yeas experience in CMC or regulatory area or equivalent experience.
Experience or expertise sufficient to support documentation of regulatory dossiers of biologics products (gene recombinant protein and antibody).
Knowledge on CMC regulations (ICH Guidelines, Standards for biological materials, etc.) and basic knoweldge on general pharmaceutical affairs (product life cycle management, etc.).
Communication and coordination skills with the ability to carry out programs by collaborating with other functions inside and outside of country.
English reading, writing and speaking skills with a motivation for further improvement (TOEIC score of 730 or above).
Effective writing skill for submission documents and response documents to be submitted to HAs.
Experience of ATMP (cell and gene therapy) or Vaccine products development in CMC Regulatory Affairs
Experience of communication with broad global stakeholders
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans