Regulatory Affairs Specialist

**_Germiphene knows infection control._** Starting over 70 years ago servicing the needs of the dental industry with our extensive product range; from disinfection, cleaning, instrument care, oral health, and hand care. Our drive for continued improvement is a daily commitment shown through new product development, strict quality standards and nurturing customer relationships. This has given us a strong foundation to grow our market to provide disinfection products, and hand sanitizers for all healthcare communities, and other government agencies.

We are innovators & manufacturers.

We are professionals.

We are educators.

We are exporters.

We are responsible.

We are looking for like-minded individuals to join our team.

Currently we are looking for a **_Regulatory Affairs _**_Specialist_**- 2-month contract**

**Job purpose**

**Duties and responsibilities**
- Develop and implement regulatory strategic plans for product registration and lifecycle management.
- Lead the preparation of regulatory submissions including New Drug Submissions (NDSs), Medical Devices, and ad hoc reports to regulatory bodies, and maintain the life cycle of currently marketed regulated products.
- Track registrations and effectively communicate with leadership team on a projects progress to ensure all critical timelines are met.
- Lead the preparation and review of responses of regulatory queries in relation to clinical efficacy and safety as needed.
- Lead interactions with Health Canada from pre-submission and throughout the submission review cycle to ensure prompt regulatory approval, optimal labeling and implementation of local regulatory strategies.
- Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and deadlines.
- Develop effective working relationships with business partners, clinical professionals and federal/provincial authorities to support regulatory strategies as needed.
- Monitor regulatory changes and applicable regulatory requirements, Identify impact of changes and/or regulations on operations and products and communicates changes across the organization
- Provide regulatory guidance and input to internal partners on messaging, labelling, SDS development and marketing materials.
- Maintain and establish product documentations, certificates of analysis and product specification documents. Maintain Regulatory documentation system, data, product Periodic safety Update report (PSUR), and status of API suppliers.
- Monitor Germiphene’s regulatory landscape, interpret changes, analyze gaps and conduct impact assessment, and participate/lead implementation into new systems and/or processes.
- Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment.
- Support Quality and Compliance activities as needed (e.g. change control, audits, etc as needed)
- Aid in achieving compliance with Domestic and International Regulatory Regimes (including but not limited to ISO 13485 specifications, GHTF Regulations, Canadian and American Medical device, Pharmaceutical, NHP etc. and GMP regulations).
- Will follow the responsibilities as outlined in the Ontario Health and Safety Act
- Other duties as assigned by supervisor

**Qualifications**

**Education**:

- University degree at a Bachelor level or greater in Science or Pharmacy or related discipline (Quality Management)
- Certificate in Regulatory Affairs would be an asset

**Skills/Abilities/Characteristics**:

- Ability to interact and negotiate with various governing authorities
- Understanding of Canadian/American/European laws and regulations as they pertain to drugs, medical devices, NHPs and cosmetics
- Demonstrable experience with the following product compliance guidelines and organizations: GHS, WHMIS, TDG, and cGMP
- Excellent analytical abilities
- Understanding of risk management
- Effective organizational skills, strong attention to detail and accuracy in order to successfully oversee regulatory initiatives, multitask and handle fluctuating workloads
- Well-developed interpersonal and communication skills (oral, written, computer-proficient) with the ability to present ideas, solutions, and strategies in a clear and concise manner
- Adaptable to changing environment, client, and project needs
- Self-motivated, possess initiative, and able to work productively with mínimal supervision
- Excellent project management and follow-up skills, deadline-oriented with a strong ability to prioritize tasks

Strong computer knowledge and Office software skills - Microsoft Word, Excel, Outlook

**Experience**:

- 2+ years working in a similar role (Canadian/International Regulatory Affairs)
- In-depth knowledge of Canadian, US, and international regulations for disinfectants, hand sanitizers and medical devices is a definite advantage
- Knowledge of various acts & regulations including HC, FDA, EPA, NNHPD, PMR