Regulatory Affairs Manager
7 days ago
**Job Summary**
We are seeking a highly skilled Regulatory Affairs Manager to join our Scientific team at Deciem. This is a full-time, permanent position based out of our head-office.
**Key Responsibilities**
- Provide regulatory guidance and strategy to R&D and business partners to support development of product programs.
- Prepare, review, and file submissions for product registrations, including ANDA/ANDS, NDA/NDS, IND, and DMF in the eCTD format.
- Determine and communicate submission and compliance requirements to key stakeholders within the company.
- Manage and lead approval of assigned new products and claims, manage changes to existing products, and maintain products in compliance with applicable government regulations.
- Develop and implement the global regulatory strategy for new product registrations and provide assessments and manage complaints from and to regulatory bodies and competitors.
**Product Labelling and Marketing**
- Review and approve product labelling and websites for accuracy and compliance to both internal and external requirements.
- 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.
**Project Management**
- Manage the regulatory affairs component of New Product Development work.
- Prioritize and manage multiple, concurrent, and often global projects within the regulatory affairs team.
- Communicate ingredient and finished product assessment results with external teams and ensure that the impact of the assessment is well understood.
**Requirements**
- 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.
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