Principal Regulatory Affairs Specialist
Principal Regulatory Affairs Specialist
AKKA Technologies
Mirandola, Italy
The Resource is expected to perform with minimal supervision and is responsible for influencing department processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. In addition, the Principal Specialist mentors’ other regulatory specialists, provides support for global regulatory approvals, and ensures compliance with company and government requirements.
Your focus will be:
- Prepare regulatory strategies/plans and worldwide regulatory requirements for both new and existing combination products/drug products.
- Writing and preparation of regulatory submissions coordinate the preparation of combination product/drug product filings.
- Respond to regulatory authorities on issues that during the review of submission dossiers.
- Interface internally with QA, R&D, Clinical and other affected departments to ensure timely availability of submission documents.
- Input, review, and approval of protocols, reports, labeling, promotional materials, training materials, and other documents used in submissions.
- Reviews, prepares and maintains regulatory files (administrative documents and technical documentation in format required by local laws, regulations, and standards) for new and/or changed products and submits to applicable authorities
- Maintenance of regulatory registration database.
- Implementation and distribution of information related to new worldwide regulations.
- Experience in define requirements WW and perform submission under Active Medical Device regulation, Pharma regulation, EUP-USP, GMP, API, Software life-cycle and cybersecurity, electrical equipment including systems, Human factors and usability, Risk management, Sterilization and biocompatibility, including reusable/re-sterilizable devices
- Pre- and post-market clinical studies support experience, CER review “Valid scientific evidence” and “substantial equivalence” topics, rationale redaction.
- Assist quality management system audits, including regulatory parts of MDSAP and EU MDR.
- Develop proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel.
Profile
Education Required:
- Bach degree in pharmacy, pharmacology, chemistry, biomedical engineering or a related subject is required. MS/PhD is preferred; Ph. D. is highly preferred.
Desired/Preferred Qualifications:
- Minimum 5 years pharma or medical device industry experience, with at least 3 years in a regulatory role involving marketing authorization for medicinal product
- In-depth knowledge of preclinical and clinical study rules/regulations.
- Thorough knowledge of other regulations pertaining to the commercialization of medicinal product.
- Thorough/Working knowledge of EMA.
- Thorough understanding of drug development process and EU drug regulations is required.
- Preparation and review of CMC sections (IN PARTICOLAR eu Localised)
- Proven experience with navigating combination product regulatory filings including request for designations.
- Experience interacting with FDA OCP, CDER and CDRH and European Medicines Agency/Pharma Competent Authority
- Experience reviewing validation protocols for laboratory equipment, process equipment, and process validation.
- Excellent written and verbal communications skills (Mandatory Italian and English)
- Highly motivated and results-oriented leader.
- Project-management skills and experience.
- Ability to be flexible with changing priorities.
- Knowledge of GCP, cGMP, and Quality System Requirement and EU and/or International product approval process.
- Regulatory Compliance competency (Inspections, Audits, Field Actions)
- International Regulatory competency
- Clinical Trial experience
- Proficiency in PHARMA compliance
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