- Develop and execute regulatory strategies to ensure successful registration and commercialization, in line with industry standards and FDA and Ireland Health Products Regulatory Authority (HPRA).
- Provide expert guidance and regulatory expertise on specific controls to ensure compliance with cGMP and other relevant standards including procedural and documentation requirement.
- Collaborate closely with cross-functional teams to integrate regulatory requirements into manufacturing processes, ensuring compliance with cGMP and other relevant standards
- Represent the company in interactions with regulatory authorities, leading discussions as needed.
- Provide sustaining product regulatory affairs support including regulatory assessments and change management.
- Liaises with client supporting business units to enable successful regulatory outcomes.
- Proactively identifies regulatory risks and proposes mitigations in collaboration
- Proactively engages in regulatory surveillance activities and provides regular analysis in support of existing/needed processes.
- Contributes to client meetings in support of pre-existing or needed filings.
- Provide regulatory surveillance to inform internal stakeholders of potential strategies, actions, and change controls for their business operations.
- Bachelor's degree required, preferably in a life sciences field.
- A minimum of 5 years' experience in prior pharmaceutical/biotechnology industry experience, including at least 6 years of relevant regulatory affairs experience in the clinical and commercial manufacturing space.
- Minimum of 10 years of relevant Regulatory Affairs experience (regionally or globally), in early and late development, commercial manufacturing.
- In-depth knowledge of the EU regulatory landscape and an extensive track record of success in regulatory affairs and related fields. The successful candidate must have a comprehensive understanding of the EU regulatory frameworks and be able to interpret and apply complex regulations to a variety of products in a commercial/clinical manufacturing environment. They must be able to quickly identify and resolve challenging regulatory issues and demonstrate a high level of technical proficiency a must.
- Demonstrated experience in pharmaceuticals development, formulation, or drug product manufacturing process development.
- Significant pharmaceutical industry experience in the CMC space. End-to-end regulatory submission and document management experience
- Experience with frequent Ex US Health Authority Inspections required
- Significant experience with QP interactions, EU Product Requirements
- Demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs
- Experience with manufacturing validation a plus.
- An understanding of global regulatory submission formats, industry standards, and guidelines, software validation concepts, and best practices.
- An understanding of the Life Sciences Business, specifically in the pharmaceutical manufacturing environment pertaining to regulatory guidance and regulatory submission assembly.
- Proficiency with EU drug development submission documentation compilation (dossiers)
- Ability to build strong relationships with global regulatory authorities.
- Expert in EU GMP requirements
- Proficiency working in Microsoft Windows environment and with Windows-based applications including, but not limited to, Microsoft Office products, Adobe Acrobat,
- Strong organizational and interpersonal skills, this individual should be detail oriented with a strong customer service focus.
- Strong written and oral communication skills, including public speaking in formal and informal educational environments.
- The ability to work well independently and in a team environment.
- Management experience preferred.
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Description
Job Description
Job DescriptionExperic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients with personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs.
We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.
Job Summary:
The Global Regulatory Affairs Compliance Manager for US/EU will play a pivotal role in shaping and leading the regulatory function within Experic. You will build and establish the regulatory framework for the US and EU. This position reports to the VP, Quality and Regulatory Affairs.
Essential duties and responsibilities include the following. Other duties may be assigned.
Education/Experience:
Competencies:
Working Conditions:
Standard office environment with less than 10% travel.
Physical Demands:
Office Environment (standing and sitting) requiring minimal physical exertion.
Experic maintains a highly competitive, performance-based compensation programs. Employees may be eligible to participate in Company employee benefit programs such as health insurance, 401k plan, disability plan, vacation pay/sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.
Experic is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
