Director of Regulatory Affairs

Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role:

Director, Regulatory Affairs

This Is What You’ll Do:

• Interpret regulations and guidance documents to advise Octapharma Plasma, Inc. (OPI) senior management on the business impact of current regulatory requirements.
• Assembles regulatory requirements and related white papers.
• Researches all regulations relative to OPI processes.
• Provides recommendation on changes to OPI SOPs/processes to comply with regulatory guidance and inspection observation.
• Author Biologics License Applications (BLA)/submissions.
• Oversee the maintenance of a Regulatory database containing establishment licensure information.
• Serve as the Regulatory representative to the Change Control Board. Review / develop change control requests and assess impact against regulatory compliance.
• Monitor trends to recommend CAPA plans for all audit activities, and report to senior management regarding process improvement opportunities.
• Develop periodic review process to evaluate all regulations for changes that may impact the organization:
• FDA and EU.
• CLIA, PPTA and OSHA.
• State.
• Local (including any public health reporting requirements).
• Biohazard waste.
• Develop and implement tracking process for all facility licenses and related regulatory submissions.
• Serve as Alternate FDA Authorized Official in order to manage the processes to achieve regulatory agency input regarding approved products.
• Present regulatory data needs, negotiate with and influences management, colleagues and partners to ensure regulatory data requirements are met. Propose and develop new/revised policies and procedures to support regulatory compliance.
• Develop systems to ensure regulatory compliance, and strive to ensure that products remain in compliance.
• Provide guidance to ensure process streamlining occurs.
• Serve as the Regulatory Affairs representative on cross-functional teams.
• Consultant to the Risk Management Team and Legal cases, where applicable.
• Consultant to HR for regulatory requirements related to hiring.
• Serve as the OPI Regulatory Affairs representative to organizations related to the plasma industry.
• Attend meetings to obtain information on upcoming changes to equipment, processes and regulations.
• Provide input to and attends focus groups allowing OPI input into the changing needs of the plasma industry.

This Is What It Takes:

• Bachelor’s degree in a life science or ten (10) years’ experience in an allied health environment with an emphasis in quality and/or compliance management.
• Seven (7) years’ direct regulatory affairs experience in a biologics, drug manufacturing, medical device facility or FDA regulated environment.
• Five (5) year supervisory experience.
• Demonstrated knowledge of cGMPs FDA regulations, SOP implementation, as well as an understanding of quality assurance principles and audit functions.
• Demonstrated excellent interpersonal, written, and verbal communication skills.
• Demonstrated decision-making ability and ability to positively influence / manage people.
• Demonstrated ability to work independently.
• Demonstrated experience working with all levels in an organization.

Do Satisfying Work. Earn Real Rewards and Benefits.

We’re widely known and respected for our benefits and for leadership that is supportive and hands-on.

• Formal training
• Outstanding plans for medical, dental, and vision insurance
• Health savings account (HSA)
• Employee assistance program (EAP)
• Wellness program
• 401 (k) retirement plan
• Paid time off
• Company-paid holidays
• Personal time

More About Octapharma Plasma, Inc.

With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.

INNER SATISFACTION.

OUTSTANDING IMPACT.