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 LSNE SOP 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

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Join us and be part of building the bridge between life changing therapies and patients.