Melanie Sorensen
Smithfield
Summary
As a senior regulatory affairs strategist leader, with a deep connection to various communities, I have the unique ability to connect regulators, technology innovators, and patient voices in way that enables drug developers and service providers. My unique ability has helped form lasting and authentic relationships with regulators, customers, suppliers and/or co-workers. Each year Melanie and her team leads many certification and registration submissions across global health authorities. I am also a pioneering member of Cytiva Regulatory Science & Intelligence leadership team, which is focused on enabling best-in-class regulatory support to Cytiva customers. My approach is rooted in collaboration, innovation, and an unwavering commitment to advancing patient outcomes through strategic regulatory solutions.
Overview
22
22
years of professional experience
Work History
Lead Regulatory Affairs Strategist
Cytiva, Global RA
08.2023 - Current
- Develops and supports the implementation of strategic regulatory roadmaps for Cytiva products and key initiatives.
- Provides exceptional regulatory guidance for various customer platforms, including advising on CTAs, INDs, BLAs, and managing regulatory submissions with Health Authorities or filing Drug Master Files on their behalf.
- Leads regulatory strategy and execution for external collaborations and product lifecycle management, ensuring adherence to global requirements and state-of-the-art standards.
- Delivers regulatory expertise to diverse Cytiva product teams and customers, covering chemical and material compliance, Chemistry, Manufacturing, and Controls (CMC), and eCTD Module 3 content, review, and strategic alignment relevant to Cytiva products and applications.
- Prepares, reviews, and submits regulatory dossiers and communications within a global framework, including the development of eCTD-ready documentation for regulatory filings.
- Oversees the strategy and management of over 50 Drug Master Files for various Cytiva products submitted to multiple Health Authorities.
- Extensive experience as a core team member on New Product Development (NPD) projects to ensure regulatory compliance and secure market access.
- Collaborate cross-functionally and global with R&D, QA, business development, product management, trade compliance and commercial to align regulatory plans with, and provide inputs and updates to business goals.
- Expert in developing and executing engagement plans with Health Authorities for assigned products, authoring regulatory communications and briefing materials, coordinating meeting preparations, and facilitating regulatory meetings.
- Recognized as a global industry regulatory leader and expert in animal serum products, having established relationships with several Health Authorities, including USDA and CFIA.
Regulatory Affairs Leader
Cytiva, Global RA
11.2019 - 08.2023
- Led global submission planning and coordination activities for complex regulatory filings, including but not limited to serum registrations, various types drug master files, and Certificates of Suitability.
- Served as a core team member on New Product Development (NPD) projects to ensure regulatory compliance and secure market access.
- Reviewed change requests/orders to ensure that compliance requirements are met and maintained.
- Served as cGMP/CMC regulatory expert and mentor for global teams.
- Maintained awareness of applicable regulations, and monitor activities related to changes to regulations.
- Supported the Leaders within the GRC team to form and drive strategies.
- Drove compliant, simple, cost-efficient and pragmatic solutions to issues related to regulatory requirements in NPD’s and other projects.
- Supported customer’s regulatory submissions that use trade secret media formulations.
- Recognized as a global industry regulatory leader and expert in animal serum products, having established relationships with several Health Authorities, including USDA and CFIA.
Quality Assurance Specialist II / Lead Quality Assurance Specialist
GE Healthcare, HyClone Laboratories
01.2014 - 11.2019
- Responsible for managing the customer audit program. Effectively hosts all audits, meeting and exceeding customer expectations to ensure a positive experience while driving compliance.
- Monitored Quality improvement as related to customer audit outputs to ensure execution of actions.
- Assisted with creating and approving Certificate of Origins, Health Certificates, Affidavits, etc.
- Direct experience of working and thorough understanding with ISO 9001, ISO13485, 21 CFR 820 and 21 CFR 210/211.
- Proficient in various QMS systems by being the lead QA personnel supporting Global Cell Culture to approve and implement new and revised specifications for all sites.
- Assisted with customer complaints.
- Lead Auditor for internal audits, ISO 13485 and 9001 Lead auditor certified.
- Trains the new employees on cGMP orientation as well as annual cGMP training for all employees.
- Reviews, approves, and releases COAs/batch records for department while making sure products are released in a timely manner.
- Approves and supports continuous product and process improvement through detailed failure analysis for non-conformance, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
- Interface directly with customers and internal groups. Review and approve documentation supporting design, qualification, and changes.
Production Technician III, BPC Assembly
Thermo Fisher Scientific
01.2012 - 01.2014
- Responsible for the manufacturing, assembly, and packaging major product lines.
- Maintains and updates PCBs, trains co-workers in processes, procedures and assembly.
- Thorough knowledge of cGMP principles.
- Works closely with the BPC inspectors and other co-workers to continually learn and be up to date with cGMP procedures and requirements.
- Continues to use many years of experience in process improvement including participating in Kaizan Events.
Project Manager
IMDS, Innovative Medical Device Solutions
01.2011 - 06.2011
- Managed all communication with customers and sales organization for facility in order to provide successful project outcomes.
- Controlled projects by developing a project plan with deliverables, and issues list in multi-tasking arrangements whether it was for a new project or an existing project.
- Oversaw all aspects of contract review, processing orders and quotations as well as resolving product and service problems.
- Knowledge in reading engineering prints for manufacturing products as well as inspection plans.
Assistant Project Manager/ EPS Specialist/ Project Manager
RR Donnelley
11.2006 - 12.2010
- Managed all aspects of electronic products including creation and data files for the facility using professional grade systems remotely and in high security data center.
- Progressively managed various projects involving consistent internal and external client service communications and solving issues in a timely manner.
- Controlled projects by developing a project plan with deliverables, and issues list in multi-tasking arrangement.
- Experience in a performance improvement role in a complex organization with reduced cycle time for processing data therefore working on more volume.
- Oversaw inventories including shipping, and other materials and ensure enough material is on hand.
- Maintained equipment and servers to make sure equipment is running efficiently.
Researcher
Caisson Laboratories
01.2004 - 01.2006
- Experience in researching plants apomixes (asexual seed formation).
- Acquired research skills, experimental design and lab equipment operation through continual on the job requirements.
- Proactively used aseptic technique with apomyx organisms in order to avoid unwanted substances or organisms to contaminate them.
- Gathered and provided a high level of accountability for the research data from other microscopists, including my own research data in order to create complex data analysis reports for final submission to the company management.
Education
BACHELOR OF SCIENCE - Biology and English
Utah State University
Logan, UT01.2007
Skills
- Establishing lasting relationships with both internal and external customers, and Health Authorities
- Team leadership qualities: Mentoring, Training, Onboarding
- Cross-functional program leadership (Reg Affairs,,QA, R&D IT, Product Management, Commercial, Manufacturing)
- Cross-functional committee leadership for industry associations
- Veeva RIMS Vault and regulatory requirement management for regulatory strategy development
- Regulatory Strategy and Submissions
- Quality Assurance and Compliance
- Veeva Quality Vault
- Business Process Improvement and Change Management
Timeline
Lead Regulatory Affairs Strategist
Cytiva, Global RA
08.2023 - Current
Regulatory Affairs Leader
Cytiva, Global RA
11.2019 - 08.2023
Quality Assurance Specialist II / Lead Quality Assurance Specialist
GE Healthcare, HyClone Laboratories
01.2014 - 11.2019
Production Technician III, BPC Assembly
Thermo Fisher Scientific
01.2012 - 01.2014
Project Manager
IMDS, Innovative Medical Device Solutions
01.2011 - 06.2011
Assistant Project Manager/ EPS Specialist/ Project Manager
RR Donnelley
11.2006 - 12.2010
Researcher
Caisson Laboratories
01.2004 - 01.2006
BACHELOR OF SCIENCE - Biology and English
Utah State University
LEADERSHIP AND VOLUNTEER EXPERIENCE
- Dynamic Teaming Leadership Course at Crotonville GE Institute (May 2018)
- Regulatory Lead of the regulatory committee for ISIA (International Serum Industry Association)
- US Regulatory Policy and US Regulatory CMC form Member for ARM (Alliance of Regenerative Medicine)
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