The Senior Regulatory Affairs Specialist assists in developing procedures to ensure regulatory compliance. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Being a Senior Regulatory Affairs Specialist typically reports to a manager or head of a unit/department. May require an advanced degree. Working as a Senior Regulatory Affairs Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature.
Senior Regulatory Affairs Specialist Job Description Template
Our company is looking for a Senior Regulatory Affairs Specialist to join our team.
Responsibilities:
- Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations;
- Provides regulatory information and guidance for proposed product claims/labeling;
- Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies;
- Identify the need for new regulatory procedures, SOPs, and participates in development and implementation;
- Provide regulatory input and technical guidance on global regulatory requirements to product development teams;
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities;
- Support TTB filings and other TTB related activities;
- Collect and use data on departmental performance to make recommendations for continuous process improvement;
- Maintain current knowledge of existing and emerging regulations, standards and guidance documents;
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards;
- Accurately maintain product information databases;
- Perform regulatory assessments;
- While performing the duties of this job, the employee is regularly required to be independently mobile;
- The employee is also required to interact with a computer, and communicate by phone and in-person with peers and co-workers;
- Support the creation of EU documentation.
Requirements:
- Proficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat;
- Strong attention to detail;
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) is required;
- Experience with Quality Management System Standard ISO 13485 is required;
- Knowledge of International Medical Device requirements (Canada, Australia, New Zealand, China, Japan, etc.) is preferred;
- Knowledge of Title 21 of the US code of Federal Regulations (21 CFR 800-1299) is required;
- Competence in applying scientific principles and logical thought processes in preparing regulatory documentation;
- Bachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred;
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required;
- Ability to work independently as an individual contributor and in a team environment;
- LOCATION United States – California – Pleasanton;
- Bachelor’s degree in scientific or legal fields (Chemistry, Biology, Nutrition/Food Science, Criminal Justice);
- Strong organizational and computer skills;
- Minimum 3 years of regulatory experience in the food or beverage manufacturing industry (FDA or USDA);
- TRAVEL Yes, 5 % of the Time.