Senior Associate, CMC Regulatory Affairs
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.
Purpose and Scope:
The Senior Associate, CMC Regulatory Affairs (RA) is responsible to support CMC regulatory activities for our company's products in accordance with global regulations and guidelines and is responsible for technical content input and coordination of CMC submissions for all assigned activities. Product responsibilities, including supporting biologics programs, could be in the development or the marketed product phase of a drug product lifecycle.
Essential Job Responsibilities:
* Contribute to preparation, compilation and transmittal of CMC submissions according to the defined schedules and meet both Health Authority and Astellas established SOPs / guidances.
* Contribute to the regulatory impact assessment of proposed CMC changes and monitors the progress of the CMC changes with regulatory impact.
* Ensure proper CMC document, including version control and metadata, and dossier management
* Support the CMC RA colleagues on assigned products and be accountable for the delivery of all assigned regulatory activities, including IND/CTA, original BLA/MAA, agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems.
* Identify, communicate and escalate potential issues to CMC RA Scientific Lead
* Contribute to collecting, interpretation, archiving, and knowledge sharing of regulatory requirements for both BLA/MAA and post-approval submissions.
* Develop an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our company's human medicinal products worldwide.
* Conduct all activities with an unwavering focus on compliance, including staying current on all training.
* Carry out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with company and regulatory requirements.
* Additional activities may be assigned by the supervisor.
* Position will interact with individuals outside of CMC Regulatory Affairs such as Global Regulatory Affairs, Quality Assurance and Pharmaceutical Technology.
* Position will provide support to multiple projects, some with overlapping timelines.
* Position should be able to apply scientific knowledge to assigned projects, and use working knowledge of relevant regulations and guidelines to assist in the success of projects and programs.
* Position reports to Associate Director, Director or Senior Director CMC Regulatory Affairs.
* Position will provide support to entire CMC Regulatory Affairs department.
* Bachelor's (minimum) or graduate degree (preferred) in chemistry, biology, engineering, or a related field. Fields of study include Chemistry, Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry or other similar scientific discipline.
* At least three (3) years of relevant experience in regulatory CMC, or biological or vaccine research, manufacturing, testing; or related fields for candidates with a Bachelor's degree or 1 year with a graduate degree.
* The ideal candidate must have the ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
* The ideal candidate must have strong organizational skills with the ability to combine information from different systems
* The candidate must be proficient in English; additional language skills are a plus.
* Experience in biologics, cell/gene therapy or vaccines preferred.
* Knowledge of FDA/EMA, ICH regulations and guidelines (and beyond), and the ability to provide interpretations of that information to others.
* Experience with Excel (pivot tables, creating overviews) preferred
* Previous experience using Trackwise and/or Veeva Vault preferred
* 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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled