Senior Regulatory Affairs Associate Jobs

Intermediate project management, time management and organizational skills

4 -10 years’ related experience and/or training or equivalent combination of education and experience

Advanced knowledge of the electricity regulated industry or equivalent experience with emphasis on rate design and cost allocation methodologies

Intermediate knowledge of Occupational Health and Safety requirements as it relates to individual, organizational and operational requirements

Senior Manager of Regulatory Affairs and Risk Management.

8 years’ experience in a supervisory role

Prepare and distribute regulatory updates to senor management and present key updates and developments to the Compliance Committee

At least 10 years of relevant experience in regulatory/fintech law.

Knowledge of applicable laws and regulations in the payment services industry.

Knowledge of gaming or data protection laws is an asset.

Experience working in a global public company is an asset.

Working knowledge of cryptocurrencies and alternative payment methods is a plus.

Manage Kosher records for ingredients and resale products

Working experience 1-2 years with Food Quality and Safety Programs and GMP’s is considered an asset

Knowledge of GFSI standards is considered an asset

Must possess strong interpersonal, organizational and problem solving skills

Must be able manage multiple priorities and deliver results within expected timeliness

Coordinate and request technical information (GMO, Prop 65, Etc.) from suppliers

oDevelop and write standard operating procedures to support MACH32’s quality management system and operations.

oManage controlled documents in accordance with MACH32’s standard operating procedures

oManage the delivery of projects, as assigned by the COO, including both internal and customer-facing.

·Strong organizational skills and attention to detail required for document control and quality affairs work.

·Experience with Microsoft PowerPoint, Excel, Word, Adobe.

·Experience working on a medical device, pharmaceutical or combination product preferred.

Excellent communication (verbal/written), interpersonal, and organizational/ time management skills are required.

Maintains up-to-date information regarding the Health Canada requirements to ensure timely review and approval of product submissions.

Manages the archiving of regulatory submissions to ensure ease of retrieval.

Minimum of four (4) years of Canadian Regulatory Affairs experience is required.

Working knowledge of Health Canada laws and regulations of OTC, NHPs and cosmetics is required.

Experience with Plain Language Labelling for OTC and NHP is an asset.

Strong organizational skills (project and records managements)

Build general scientific knowledge of assigned portfolio and of cross-functional roles/responsibilities

Build and maintain knowledge of Regulatory requirements and Health Canada regulations, policies/guidelines

Strategic Planning and Product Lifecycle Management

Manage Regulatory filings & review/approval process for products in portfolio to secure timely approvals

Manage and summarize ongoing issues and HC queries to develop plan of action, along with team prepare response and ensure resolution

Adverse event reporting – assess reportability, prepare and submit reportable ADRs, record management, annual safety reports, etc.

2-5 years regulatory affairs work experience/education.

Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines.

Functional, previous experience in regulatory affairs submission preparation and familiarity with TPD/FDA/ICH guidelines.

Good working knowledge of current Canadian Food and Drug regulations, GMP guidelines and policies.

ECTD submission experience (familiarity with Lorenz docuBridge is an asset).

Project management experience with excellent interpersonal, presentation and communication skills.

Three or more years complex worldwide CMC regulatory strategies/requirements and demonstrated ability to influence the global internal/external regulatory environment. 

Two or more years of experience managing and directing multiple projects/teams in a high matrix environment.

One or more years of experience fulfilling a key role in major filing activities.

Experienced in supervising and training junior staff and the ability to motivate and lead others.

Managing the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.

Knowledge of submission requirements and timelines

Collaborate with global and local teams to manage critical timelines.

Post-secondary degree or relevant work experience

3-5 years of experience pharmaceutical/OTC industry experience in Regulatory Affairs

3-5 years of experience with submissions and negotiations with Health Canada

3-5 years of experience in OTC or Consumer Healthcare

A working knowledge and experience in CTAs, paediatric investigation plans and orphan designations.

Experience in regulatory affairs in pharmaceuticals and previous experience of managing teams.

Demonstrated experience of contact and relationship with MHRA and HPRA.

Responsibility of all UK/IE assigned Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.

Formulate regulatory strategies for all products within the team for new submissions and post approval changes.

Lead or participate in preparations for health authority meetings and effectively chair discussions

Knowledge, Experience & Skills Required

Acts as a knowledgeable resource on limited topics to other Regulatory Affairs personnel within the department.

5+ years of relevant regulatory experience in the prescription pharmaceutical industry - experience in both clinical and CMC considered an asset.

Post-graduate certification in Regulatory Affairs is considered an asset.

Experience in Virology or Oncology considered an asset

Understanding and knowledge of the fundamentals of Canadian regulatory legislation and guidance.

Adhere to requirements of the Quality Management System.

Working knowledge of relevant EU regulatory requirements for medical devices including Quality Systems standards

A minimum of a bachelor's degree or equivalent work experience

Previous experience with EU MDR notified body reviews for Class III devices

Experience working directly with notified bodies is desired

Coordinates, compiles, and submits CE Mark submissions under the EU MDR

Detail oriented and good project management skills

Comprehensive total rewards benefits package including Health and Dental benefits that start on day one of employment

Access to Educational Assistance & Tuition Reimbursement

Additional discounts on a variety of products and services offered by our preferred vendors and partnerships

An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program or industry experience are assets

A team player with strong interpersonal and communication skills

Be a valuable member of our risk management team, contributing from a regulatory perspective to risk assessment exercises and documents

Build partnerships, internally and externally, to provide routine updates and ensure compliance with regulatory requirements

A minimum of 3 years of experience in regulatory affairs within the medical device or life sciences industry

Proven experience in compiling and submitting pre-market regulatory submissions, such as 510(k), De novo, and IVDR Technical Documentation

Collaborate with cross-functional teams to provide regulatory inputs during the design and development phase of our devices

Compile pre-market submissions, including pre-submissions, 510(k), De novo, and IVDR Technical Documentation as necessary

Minimum 12 years relevant experience out of which more than 5 years of people manager role

Responsible for Canada's regulatory strategy of both products approved and products under development.

Will serve as the point of contact for the Agency’s interactions and act as local regulatory representative

Supports the development of Canada's regulatory policy priorities, generates policy positions, and develops action plans.

Responsible to prepare, review and approval of module 1 sections in partnering with GRL and make them available for NDS submission

Assist the North America head-on product development strategy and participate in building the regulatory strategy.

Industry knowledge - comprehensive knowledge of NI 31-103 and other applicable regulatory requirements

Proactively improving and iterating on internal controls designated to manage regulatory risk

Compliance experience - 3+ years of investment industry experience

Business judgment - demonstrated ability to link business imperatives and regulatory requirements; business creativity and problem-solving mindset

Excellent interpersonal skills and willingness to work in collaboration with various team members

Analytical - strong analytical and problem-solving skills with superior attention to detail; ability to exercise strong judgment in gray areas

Acts as a knowledgeable resource on limited topics to other Regulatory Affairs personnel within the department.

Post-graduate certification in Regulatory Affairs is considered an asset.

Experience in Virology or Oncology considered an asset

Understanding and knowledge of the fundamentals of Canadian regulatory legislation and guidance.

Excellent planning and organizational skills and the ability to work simultaneously on several projects with tight timelines.

Excellent communication skills both in writing and verbally.

Report trends from product feedback to support continuous improvement, vigilance activities and management reviews

Knowledge of the requirements of an ISO 13485 quality program

Experience using database software to manage data and records is an asset.

Maintain current body of knowledge on regulations and standards that may impact regulatory approvals for products currently being marketed

Certificate in Regulatory Affairs or equivalent work experience

Minimum of 5 years of regulatory experience in a medical device environment

Management experience in Regulatory Affairs or large engineering projects

2 or more years of experience with Canada nuclear requirements and guidance

Minimum of 1 year of experience involving complex projects, and providing regulatory guidance and feedback to support those projects

Experience and demonstrated effectiveness in working / communicating with nuclear regulators

Experience working with nuclear industry groups

Effective interpersonal and facilitation skills

Excellent skills in data management, information analysis and report writing.

Effective time and project management skills - Plans and organizes to meet deadlines

Skill Factors (education, experience, communication, technical, etc.)

Strong oral and written communication skills as well as presentation abilities.

Keeps current on regulatory requirements through self-study/attendance at conferences/training seminars.

Greater than five years Regulatory experience (or related fields)