Senior Regulatory Affairs Specialist
تفاصيل الوظيفة
The successful candidate will play a key role in the execution of business strategy and corporate initiatives and will be responsible for supporting the Regulatory Affairs Department in regulatory activities to ensure corporate goals are achieved in a compliant manner. This role will play a vital part in devising, recommending, and implementing regulatory compliant strategies to support business, while working closely with the Research & Development team to accomplish these goals. The incumbent must have a solid scientific background and knowledge of/experience with the regulation of Dietary Supplements/Natural Health Products. Accountabilities:
- Understands departmental needs and business requirements to deliver projects on schedule and within budget
- Lead, mentor, and train the team consistent with company policies, guidelines, and standards
- Review and sign-off on product labels, product development briefs, change control documentation, and formulations in accordance with appropriate regulatory framework, ingredient specifications, manufacturer information, etc.
- Support US, Canadian and International new product research and development by the evaluation of formulations and labels for compliance
- Provide after-market US, Canadian and international regulatory support for Iovate products
- Monitor and report developments in the regulatory world with direct relevance to Iovate
- Demonstrate an ability to monitor, inform, suggest, recommend and apply, after necessary approval from manager, actions necessary to meet and maintain regulatory (food and dietary/nutritional supplements) compliance
- Review ingredient substantiation for compliance in US and international markets
- Prepare profiles and review labels for US, Canadian and International products
- Monitor processes and ensure departmental SOPs are followed. Ensure SOPs are relevant and updated as needed
- Coordinate and prepare documentation for international customers and product registrations
- Challenges the status quo and looks for innovative ways to continually improve processes
- Liaise with Regulatory Counsel and/or Consultants, as necessary
- Other role related duties as assigned
- Post-Secondary Education in Science, Biology, Nutrition, Toxicology or related field
- 5+ years of regulatory affairs experience preferably within a consumer-packaged goods regulated environment (strong recommendations for directly dealing with the US FDA and/or Health Canada)
- Experience in science-based documentation
- Strong knowledge of at least one of the following: US Dietary Supplement and/or Food Regulations (DSHEA), or Canadian Natural Health Products and/or Food Regulations; knowledge in the following would be considered an asset: European Food Supplement Regulations, Australian Therapeutic Goods and Food Regulations, LATAM Food Regulations, MENA Region Food/Pharmaceutical Regulations
- Proactive and able to continuously manage change in an extremely fast paced, energetic work environment
- Leadership and coaching skills; outstanding communication and problem-solving skills
- Proficient in the use of MS Office Suite
- World class gym, fitness classes and external basketball court
- Community involvement through charitable events
- Competitive compensation package
- 100% Group Health & Dental Coverage
- Employee Assistance Program
- Company RRSP Matching
- Paid vacation & 5 personal days
- Employee Engagement Events
- Product & Swag from our industry leading brands
- Professional career development
- Opportunities for Global career exposure without the need to relocate!
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