Senior Manager, Regulatory Affairs, Product Safety & Toxicology

We are looking for a Senior Manager of Regulatory Affairs, Product Safety & Toxicology (OTC) to join our Scientific team on a full-time, permanent basis.

This position will be based out of our head-office in Liberty Village .

WHAT YOU’D BE DOING IN THIS ROLE

Product Registrations

• Providing regulatory guidance and strategy to R&D and business partners to support development of product programs
• Preparation, review and filings of ANDA / ANDS, NDA / NDS, IND and DMF in the eCTD format. Preparation, review and filings Rx to OTC Switches.
• Determine and communicate submission and compliance requirements to key stakeholders within the company. Work with the impacted teams to ensure that the requirements are understood and executed.
• Manage and lead approval of assigned new products and claims, manage changes to existing products and maintenance of products in compliance with applicable government regulations.
• Develop and implement the global regulatory strategy for new product registrations and provide assessments and manages complaints from and to regulatory bodies and competitors, in collaboration with legal and marketing.

Product Labelling and Marketing

• Review and approve product labelling / websites for accuracy and compliance to both internal and external requirements and collaborate with internal departments to ensure that product claims and advertising are compliant and competitive.
• Provide guidance in the submission of dossiers to advertising pre-clearance agencies to obtain approval for competitive consumer and professional advertising.
• Develop and maintain scientific expertise concerning assigned therapeutic and / or functional area in order to advise the business on new opportunities, help develop new claims and be aware of (and be able to respond to) emerging competitive, regulatory and NGO threats.
• Maintain vigilant oversight of developments within the assigned therapeutic and / or functional area, communicating key competitive takeaways to business partners.

Project Management

• Responsible for managing the regulatory affairs component of New Product Development work which will require the ability to work collaboratively with departments to implement changes or new systems.
• Responsible for prioritizing and managing multiple, concurrent, and often global projects within the regulatory affairs team.
• Responsible for communicating ingredient and finished product assessment results with external teams and ensuring that the impact of the assessment is well understood.

SKILLS AND QUALIFICATIONS NEEDED TO GET THE JOB DONE

• University degree in a scientific field (Life Sciences, Chemistry, Pharmacology / Toxicology or Pharmacy).
• 10+ years of experience in regulatory affairs including direct experience in the submission and shepherding of product registrations for drug products with a focus on Canadian, USA, UK, and European Union regulatory schemes.
• 5+ years of leadership or management experience.
• Demonstrated proven record of past achievement of negotiating product approvals with regulators and innovating regulatory strategies.
• General understanding of the regulatory framework for cosmetics and personal care products.

WHAT YOU’LL BE GAINING BY JOINING OUR TEAM

There’s a lot of good stuff that comes along with being a DECIEM team member. Here’s a few of our favourite perks and benefits, in no particular order

• Generous Vacation & Personal Days, plus additional time off for volunteering in your community, voting, peaceful protesting, celebrating your birthday, and more.
• 6 months of paid time off for new parents (inclusive of all genders).
• Work from anywhere 4 weeks per year.
• A hybrid work model (for applicable roles).
• Summer Friday’s - get off at 1pm all summer long! (for applicable roles).
• Unlimited access to an Employee Assistance Program that includes mental health care, mindfulness programs, and more.
• Access to Development Grants & a LinkedIn Learning membership to help you keep growing and learning.
• A generous discount on DECIEM products for you, your family, and your friends.
8 days ago