Associate Director, Regulatory, Biologics
Astellas

Job Info

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.



Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.



AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.



Astellas is announcing a Associate Director, Regulatory opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.



Purpose:

This position will support key regulatory activities, supporting the development and commercialization of AIRM's products. The focus will be on developing and implementing CMC regulatory strategies as well as coordinating all aspects of CMC regulatory submissions.



Essential Job Responsibilities:


* Provide strategic guidance regarding FDA and global regulatory requirements for development and registration of AIRM's products.
* Compile, review, approve and submit CMC applications, amendments, and supplements.
* Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
* Provide guidance and support to AIRM staff regarding global CMC regulatory matters.
* Act as the primary regulatory representative at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
* Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
* Manage contract staff and vendors as needed to support regulatory activities.
* Provide creative and innovative solutions while being an advocate for compliance.
* Research and disseminate regulatory intelligence on trends in US regulatory affairs in the CMC biologics space and industry standards for CMC Regulatory work.



Quantitative Dimensions:


* Support to enrich and advance internal early stage portfolio.



Organizational Context:


* The Associate Director, Regulatory reports to Director, CMC Regulatory



Qualifications:

Required:


* Bachelor's degree in Life Sciences with 10+ years of experience in Regulatory Affairs, or 8+ years with an advanced degree with a minimum of 4 years in Manufacturing and Control (CMC) regulatory environment.
* Ability to manage multiple projects/submissions concurrently.
* Strong technical writing and editing skills.



Preferred:


* Experience with biologics specifically cell and gene therapy products.
* Knowledge of eCTD elements and structure


Benefits:


* 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

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled