Regulatory Affairs Manager

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November 14

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Recruiting.com

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Recruitment • SaaS • B2B

Recruiting. com is a recruitment platform that collects personal and non-personal information from job seekers to be used by recruiters and hiring managers. Users can submit their resumes or fill out a short form to be considered for current and future job opportunities. The site emphasizes user privacy and allows users to manage their personal data, including modifying, changing, and deleting their information. Recruiting. com securely stores user data until they request deletion, providing a comprehensive recruitment solution for both job seekers and employers.

11 - 50 employees

🎯 Recruiter

☁️ SaaS

🤝 B2B

💰 Private Equity Round on 2006-06

📋 Description

• Co-ordinate and compile regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects • Participate in cross functional teams to support regulatory strategies and help achieve business results • Identify client and dossier issues and develop effective strategies to address them, consulting with others as needed • Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with clients/agencies • Prioritize and monitor assigned projects to meet budget (including invoice review), timelines and client expectations, identify and communicate emerging issues • Follows Innomar and client best practises and SOPs to ensure quality and control of documents • Maintain and expand professional regulatory knowledge in order to provide effective consulting service • Support client proposals and new business activities as assigned • Ability to travel as necessary, passport required

🎯 Requirements

• B.Sc. (advanced degree preferred) in Life Sciences (Microbiology, Biology, Chemistry or Pharmacy preferred) • Certification in Regulatory Affairs (RAC) and other relevant certifications an asset • Comprehensive knowledge and hands-on experience working with biologic products, including regulatory considerations • Proven ability to author Module 3 (M3) and Module 2.3 (M2.3) documents in compliance with regulatory standards • A minimum of 5 years of Canadian Chemistry, Manufacturing, and Controls (CMC) regulatory experience • Direct experience and working knowledge of a wide range of regulatory submission types • Strong working knowledge of local Health Authority regulations, guidelines and policies • Effective time management and multi-tasking skills • Demonstrated strategic planning and problem-solving skills to resolve issues effectively and efficiently • Strong business and financial acumen • Strong analytical and mathematical skills • Effective organizational skills; attention to detail • Ability to consistently meet deadlines • Ability to communicate effectively both orally and in writing • Demonstrated ability to work in a cross-functional, multi-disciplinary team environment • Knowledge of computers, to operate effectively with Adobe Acrobat, Microsoft Word, Excel spreadsheets, and Microsoft Outlook

🏖️ Benefits

• medical, dental, and vision care • backup dependent care • adoption assistance • infertility coverage • family building support • behavioral health solutions • paid parental leave • paid caregiver leave • training programs • professional development resources • mentorship programs