Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

　　We are PCI.

　　Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

　　The Principal Regulatory Affairs - CMC Specialist will support the preparation of CMC regulatory submissions in support of client Investigational/ Commercial Drug/ Biologic applications and site maintained drug master files.

　　Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

　　Author the CMC sections of client regulatory submissions

　　Author responses to requests from regulatory agencies

　　Author regulatory memorandums and statements

　　Serve as a regulatory point of contact for clients

　　Author sections and amendments to current and future Type V DMFs

　　Assist in maintaining site regulatory documents (Site Master File and local State Licensure)

　　Ensure site compliance with cGMP and applicable PCI SOPs through Regulatory Change Notification system

　　Work effectively on cross-functional teams and be the regulatory CMC contact for assigned products and projects

　　Assist as directed during client audits / regulatory inspections.

　　Assist with site registration submissions for company and all its subsidiaries

　　Assist with applications for new/renewed individual state licenses

　　Author RA department SOPs and associated documents

　　Create gap assessments for applicable regulations and guidance

　　Research information as pertains to meeting company and client needs

　　Author Elemental Impurity / Residual Solvent Risk Assessments

　　Summarize procedures/protocols/guidance as needed

　　Contact vendors/suppliers for support of RA activities

　　Other duties as assigned

　　Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

　　PROFESSIONAL SKILLS

　　Excellent verbal and written communication skills

　　Exceptional customer service skills

　　Exceptional organizational skills and attention to detail

　　Ability to make risk based decisions and resolve issues with minimal guidance.

　　Proficiency in MS Office including Word, Excel, Outlook, Smart Sheet

　　Strategic and creative thinking with strong problem-solving skills

　　Expert knowledge of cGMP, FDA, EMA, ICH, desirable to have global experience in Latin America and other regions.

　　EDUCATION

　　JD with life science degree (preferred) or MS University degree in Life/Health Sciences

　　RAC certification preferred

　　EXPERIENCE

　　Expert knowledge in CMC regulatory (FDA, EMA, Health Canada, ICH, Rest of world) guidelines

　　Expertise in assisting in the preparation, including writing, of CMC submissions supporting submissions such as IND, NDA, BLA, etc.)

　　Extensive knowledge of sterile drug manufacturing, some knowledge of oral solid dose manufacturing is desirable.

　　Understanding of the end-to-end drug development process, especially aseptic manufacturing, and QC testing20 + years of pharmaceutical or biotech industry experience; medical/ combination device experience is a plus

　　10 + years of regulatory affairs, CMC experience (or relevant experience)

　　QUALITIES

　　Ability to work in a dynamic, fast paced work environment

　　Ability to work independently and/or part of a team

　　Ability to provide outstanding customer service

　　A collaborative individual, who listens effectively and invites response and discussion and who communicates in an open, clear, complete, timely, and consistent manner

　　Strong sense of planning and prioritization, and the ability to work with all levels of staff and management

　　Capable of strategic thinking with ability to resolve complex and ambiguous situations, understanding and applying scientific principles and regulatory requirements.

　　COMMUNICATIONS & CONTACTS

　　Interacts with all department staff

　　Share training/presentations to large or small groups

　　Client facing position requiring excellent verbal, written communication, and customer service skills

　　#LI-LL1

　　Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

　　Equal Employment Opportunity (EEO) Statement:

　　PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

　　Why work for PCI Pharma Services?

　　At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

　　PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled