GMP Regulatory Compliance Specialist
3 days ago
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.
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.
Job Details:
The Regulatory Specialist is responsible for providing support for all internal/company and external/client regulatory-related activities. The position will collaborate with internal team members, including but not limited to those in QA, QC and Manufacturing to maintain compliance with regulatory requirements.
Responsibilities:
- Identifies relevant guidance documents, international standards, or consensus standards and provide interpretive analysis.
- Obtains and distributes updated information regarding domestic or international laws, guidelines, or standards.
- Communicates with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Provides technical review of data or reports for regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
- Prepares submissions of license applications and renewals.
- Tracks and maintains licenses and company submissions as required by applicable regulatory agencies.
- Collects, collates, and evaluates data for routine internal and customer regulatory reports.
- Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Prepares or maintains technical files as necessary to obtain and sustain product approval.
- Prepares or directs the preparation of additional information or responses as requested by regulatory agencies.
- Prepares responses to customer requests for information.
- Participates as an inspection team member during regulatory inspections.
- Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
- Bachelor's degree in a Life Sciences discipline or equivalent required.
- Minimum of 4-6 years of experience in regulatory affairs, QA, or equivalent.
- Familiarity with cGMP regulations 21CFR parts 11, 210, 211 and 600, EudraLex Volume 4, cGMP guidelines and good documentation practices.
- Familiarity with fill finish manufacturing batch record structure strongly preferred.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Strong organizational and analytical skills.
- Must be proficient with Microsoft Office applications.
The base salary range for this position is $76,000.00 to $85,500.00 plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
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.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
#LI-KC1
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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