Astellas Pharma Document Request Coordinator 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 and Scope:
This role acts as single point of contact to request documentation issued by Health Authorities (e.g., GMP, CPP, Manufacturing License) and to coordinate the preparation of other Module 1 related documents, in collaboration with various stakeholders within and outside Astellas.
It also collects and archives regulatory files from across the region and creates the technical Files to ensure that all information is captured.
Works under the direction of the RA Executive Director for Latin America and LATAM RA members; initiates, coordinates, and execute solutions to regulatory operational processes. Advises regional teams on regulatory requirements, identifies and collects data required for regulatory filings and registrations packages. Supports RA-LATAM team in the preparation registration packages, response to action letters, maintenance of filings and approvals. Takes responsibility for the development and implementation of regulatory operational processes within the department.
Works closely with other individuals/groups in Regulatory Affairs across regions to influence others to ensure departmental consistency and identifies options for risk discussions.
Ensures appropriate and sustained support for all related requests (CPP, GMP, QA/CMC related documents, Module 1 documents, e.g. Site Master File, Certificates of GMP compliance, HA Inspection Reports, legalization of certain documents, just to name some).
The DRC role also acts as coordinator for these non-product specific GMP related applications, in direct collaboration between Affiliates, the plants, and the licensing Business Partner whenever applicable.
Archives of correspondence in Veeva Vault for LATAM countries for the following documents: Proof of submission, Deficiency Letters, Approval letters and all documents sent and received to/from the Health Authorities associated to the corresponding applications.
Essential Job Responsibilities:
This position coordinates the necessary documentation for the development, preparation and implementation of regulatory strategies to maintain, and extend product development and registrations in the INTL-GCN region, in alignment with Therapeutic Areas for maintenance activities.
Provides proactive guidance to internal groups, affiliates and/or business partners based on technical and regulatory knowledge towards development of strategic and tactical plans throughout the lifecycle of the product.
Provides input for RA cross functional projects from region. Actively works with project management and Regulatory Operations to ensure appropriate planning, tracking, and alignment of content and timelines for regulatory submissions across indications and compounds in the Region.
Coordinates and monitors the preparation of administrative documents and GMP (Good Manufacturing Practice) related documents for various submissions including, but not limited to, Company registration applications, GMP inspections applications, Marketing Authorization Applications (MAAs) and their maintenance, in collaboration with internal and external manufacturing sites, CMC-RA, Ptech, QA and Affiliates / Business Partners, as applicable.
Develops professional relationships and acts as main contact with internal and external manufacturing sites for administrative and GMP related documents requests.
Provides guidance to all appropriate departments to ensure compliance with applicable regulations. Remains knowledgeable about current regulations and guidance, including interpretation of regulations/guidance and notification of appropriate Astellas personnel.
Contributes to regulatory and other company-wide and departmental policies and standard operating procedures.
Interacts with peers in other regions within RA-INT to ensure alignment any synergy of strategies.
Manages complex technical documents for preparation, review and submission to regulatory agencies.
Impacts the company's overall success including overall sales and risk management. Failure to perform functions could result in significant regulatory compliance issues.
Contributes to positive impact on strategic regulatory decisions for assigned projects.
This position reports to the RA LATAM Head in the International & Greater China Regulatory Affairs organization.
Bachelor's degree in scientific discipline required; advanced degree preferred.
1-3 years previous experience in pharmaceutical companies or equivalent.
1-3 years previous experience with submissions in the Sub-Region.
If applicable: Fluent in English, Spanish or other relevant languages appropriate to the sub-region.
Strong scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development. Recognized as an expert in an aspect of pharmaceutical drug development.
Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to internal stakeholders and others in the department as needed.
Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards.
Ability to communicate effectively with cultural awareness and sensitivity and maintain effective working relationships.
High integrity with respect to maintenance of proprietary, confidential information.
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
Category Regulatory Affairs
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans