Regulatory Affairs Specialist – Pharma
Our team in Etobicoke currently has an opening for a Regulatory Affairs Specialist Pharma
YOUR ROLE & RESPONSIBILITIES
- Supporting the regional Pharma division Sales Team on topics including regulatory, legal, compliance, quality and product safety.
- Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA’s & TA’s) in and English.
- Contribute as part of team to maintenance of EMEA document management system to keep product and supplier information up to date.
- Request product and supplier information directly from manufacturers and indirectly via other internal channels.
- Process Change Control Notifications.
- Maintain customer specific information such as completed questionnaires, supply chain agreements, QAA’s, TA’s in the designated database.
- Creation and ongoing update of product regulatory information in standardized information packs.
- Support of customer, regulatory and 3rd party audits.
- Reporting and documenting customer requests via KPIs.
YOUR PROFILE
Education and Experience :
- 2 years previous experience working with regulatory documentation.
- Knowledge of ISO9001, food safety or GxP systems.
- University degree in life sciences
- Knowledge of pharmaceutical industry requirements and regulations on APIs, Excipients and starting materials.
- Previous experience with the FDA (or another national competent authority) and their requirements.
- Team player, strong communication and interpersonal skills, with ability to work across all levels, and functions
OUR OFFER
- We aim to create an environment where the best people want to work, where they can turn their passion into their job and realize their full potential.
- Individual development, on-the-job training, and development programs designed to help our employees grow in their careers.
- Competitive pay and incentives.
- Various healthcare plan options as well as 401(k).
Regulatory Affairs Specialist – Pharma
Our team in Etobicoke currently has an opening for a Regulatory Affairs Specialist. PharmaYOUR ROLE.. Support of customer, regulatory and 3rd party audits.Reporting and documenting customer requests via..
Regulatory Affairs Manager
Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational.. facilities ldentifying creative solutions for overcoming regulatory challenges Identifying new..
Regulatory Affairs Associate
Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational.. facilities ldentifying creative solutions for overcoming regulatory challenges Identifying new..
Manager, Regulatory Affairs
MANAGER, REGULATORY AFFAIRS FULL TIME OTTAWA OR TORONTO Are you in expert in health products regulations.. They are looking for an expert in regulatory affairs with a learning mindset and determination to be a..
Regulatory Affairs Submission
Skills Required. B.SC. in Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry or.. Good years of experience in Pharmaceutical Quality Control Quality Systems. Understanding of..
Regulatory Affairs Specialist
Legal Medical Regulatory (LMR) committee review.Subject matter expert with respect to privacy for LEO.. Report any health or safety concerns (internal and external) in compliance with LEO Pharma policy and..
Senior Advisor/Advisor, Regulatory Affairs
Advanced degree (e.g., MSc, PhD, MD) preferred 7. years of progressive experience in regulatory affairs and clinical development within the medical device or pharmaceutical industry, with a..
Head of Regulatory and Clinical Affairs
Advanced degree (e.g., MSc, PhD, MD) preferred 7. years of progressive experience in regulatory affairs and clinical development within the medical device or pharmaceutical industry, with a..
Regulatory Affairs Officer
Job DescriptionJoin our team of experts in regulatory and ethics submissions of clinical studies! You.. years of hands on relevant Regulatory Affairs experience.Experience with the review, maintenance, and..
Regulatory Affairs Officer.
Job DescriptionJoin our international team and be the key support to clinical research projects, part of the start up team, working in a dynamic multi functional environment, gaini..