Regulatory Affairs Associate

6 days ago

Mississauga, Canada Bayer Full time

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Regulatory Affairs Associate**

The Regulatory Affairs Department of the Consumer Health Division is primarily concerned with maximizing and protecting the commercial interests of Bayer. It is concerned with the registration of new products and compliance of existing products according to federal and provincial regulations. The department should identify solutions that resolve critical issues that would affect the bottom line of the business and ensure strategies identify all critical unique selling points, are efficient from a cost and timing perspective and can gain approval.

The Regulatory Affairs Associate (RAA), in consultation with the Manager, Regulatory Affairs, is responsible for managing assigned brands and projects to meet the requirements of the Regulatory Affairs Department including developing strategies and preparing regulatory submissions for new products or indications. The RAA is responsible for developing and maintaining a close working relationship with Marketing, Sales, Quality Assurance, Project Management, Legal and R&D groups, so that drug development, filing of submissions and maintenance of product compliance, are undertaken in a timely manner, and consistent with applicable Federal and Provincial Regulations. RAA will develop and maintain excellent working relations with Health Canada, Provincial Regulatory Bodies and Industry Association taskforces.

Bayer is committed to a flexible hybrid working environment.

**What you will do**:
Submissions
- In consultation with the Regulatory Affairs Manager, develop submission strategies and ensure all possible avenues are explored and the most efficient route is chosen
- Manage the preparation of regulatory submissions, their filing, negotiations, and amendments, which includes obtaining, assessing and summarizing scientific and other technical information
- Maintain contacts with Federal and Provincial Regulatory Authorities and Industry Associations when required

New Product Assessments/ Product Launches
- Work with Marketing, Legal, Quality Assurance, Project Management, R&D and Regulatory Affairs in the development and review of product strategies
- Assess formulations against regulatory requirements during drug development; provide input on clinical development plans etc.
- Work with Medical department to develop standard responses (for new questions, product launches etc.) as well as responses for escalated consumer complaints

Compliance
- Ensure continual regulatory compliance of all products due to changes (e.g., Labelling (CCDS), Quality changes)
- Ensure procedures and processes are followed to ensure compliance with Federal and Provincial regulations and Industry Codes.
- Update Working Instructions as required.

Advertising/Promotions
- Review and approve all advertising, external communication, and promotions. Work with Marketing/Sales to find creative solutions.
- Negotiate ASC and PAAB approvals

Labelling
- Develop regulatory compliant labelling for all products
- Negotiate approval of labelling
- Review and approve artwork routings of labelling

Shaping of Regulatory Environment
- Develop and provide informed analysis regarding Health Canada draft regulations and guidelines or other governing or regulating bodies proposals

**Who you are**:

- B.Sc. or higher in Biological Sciences, Pharmacology, Toxicology or Chemistry; Regulatory Affairs Certificate preferred
- Working knowledge of Food and Drugs Act and Regulations or Natural Health Products Regulations
- Experience in submitting and managing components of a SNDs (including clinical summaries, C&M, bioequivalence etc.) administrative changes, Labelling Standards, and/or experience with non-compendial NPN submissions;
- Experience in reviewing consumer and HCP advertising
- Demonstrated success in the OTC regulatory environment and knowledge of drug development (chemistry and manufacturing clinical studies, etc.) in the innovative pharmaceutical industry
- Preferred 1 year experience in Regulatory Affairs, ideally experience in OTC Regulatory
- Ability to build and maintain strong and collaborative working relationships with internal and external contacts
- Ability to work independently and under pressure

This position requires full vaccination against COVID-19.

**What we offer**:

- Competitive compensation and rewards package
- Collaborative, diverse and inclusive culture

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