Regulatory Affairs Compliance Manager (Global/EU)
Experic
- Cranbury, NJ
- $120,000-150,000 per year
- Permanent
- Full-time
- 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.