Senior Regulatory Affairs Cmc Project Manager 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

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.

• 8 years of combined previous experience as a Project Manager/Project Coordinator or related field

• Working in tandem with another Project Manager to support the initiative

• 4+ years of previous experience with regulatory & business projects

• Experience with MS Project Plan/PowerBI

• Experience with Excel & MS Office

• Previous experience in the financial industry

Project management & organizational skills

Regulatory Inquiries and Examinations Management:

10 to 15 years’ experience in financial sector. The role is open to Senior VPs who would meet the requirements below.

Ability to work both independently and collaboratively with members of the management team and other colleagues across the bank

Ability to interact with experienced managers (COO, CEO level) and provide effective briefs on risks and issues

Sharing knowledge with the business and organizing preliminary impact analysis

Strong business analysis and project management skills required, including a deep understanding of translating customer business needs into technology requirements.

5+years business and/or technology experience, including business analyst or project manager in a pharmaceutical, technical, financial (or other regulated) industry.

Analyze business needs, bring together, document and assess business requirements from partners and define a case for a technology solution.

Develop and monitor continuous improvement activities, including measuring existing systems against changing business requirements to determine enhancements and process improvements.

Minimum 3 years’ experience in Pharmaceutical / Life Sciences regulated environment (GxP) QC, Clinical/Medical or Drug Safety experience.

Solid understanding of medical/clinical terminology, roles and responsibilities

Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)

nterested? For this position you’ll need the following education, experience and skills

Regulatory experience in combination products or drug delivery devices

Extensive experience of participating in regulatory agency meetings on CMC matters

Effective interpersonal, presentation and communication skills with established internal and external stakeholders

Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills.

Project management skills with a demonstrated ability to write detailed technical reports;

Evaluating Request for Proposals and prepare responses, develop work scopes, budgets and schedules, and providing project management;

Willingness to occasionally travel, including to remote locations and outside standard office hours;

Managing projects related to renewable energy, transportation, industrial development, infrastructure, mining and oil and gas sectors;

Managing projects and our clients simultaneously while fostering a collaborative and inclusive team environment;

Acting as a mentor for junior staff and collaborate regionally and nationally with other EIA practitioners;

Previous film & TV industry experienced considered an asset

Minimum of 5+ years of experience in a similar role

Ensure compliance with industry regulations (CAVCO, CRTC)

Advise on legal and business matters

Work closely with various unions and guilds (directors, writers, actors and crews)

Coordinate with external legal counsel

Consult and contribute to POINT’s Project Management knowledge and processes.

1+ years of project management experience

Experience with Asana, JIRA, MS Project, and/or similar project management tool(s)

Prepare and maintain project plans, obtaining management approval and project team buy-in; liaising with external vendors as appropriate.

Maintain project documentation to promote engaging project team environment, including document management (Sharepoint), taking minutes, updating project timelines, etc.

Communicate proactively with stakeholders and management regarding project risks, delays, and high-impact tasks, along with proposed mitigation plans.

Collaborate with internal partners (e.g., Regulatory Publishing, Project Management, Business Systems, etc.)

Contributes to development and maintenance of policies and/or Standard Operating Procedures and related document management processes.

Proficiency in RIM - Regulatory Information Management system - preferred but not mandatory

Project management: consistently achieves multiple tasks and goals on-time

Facilitates communication and collaboration to meet submission timelines and plan future requirements.

Facilitate knowledge sharing and best practice workshops contributing to continuous improvement

Foster a positive can-do attitude with a willingness to expand skill set and responsibilities.

PhD in Biochemical/Chemical Engineering, Bioengineering, biochemistry or related discipline with 5-10+ years of relevant biotech industry experience.

Candidates with BSc/MSc degrees and 8+ years of relevant biotech industry experience will also be considered.

Experience of operating industrial CHO cell-based fed-batch processes using chemically defined media and feeds with microbioreactors and benchtop bioreactors.

Detailed knowledge of mammalian cell culture bioreactor design, engineering principles, and scale-up.

Working knowledge of CHO cell biology and metabolism.

5+ years of Quality System management experience, preferably in performing, facilitating, and managing risk assessments

Monitoring and ensuring current and new QRM regulations, guidelines and industry expectations are appropriately implemented into the Quality Management System (QMS).

You are passionate about building dynamic new teams and capabilities that accomplish important goals

Continuously driving improvements to the established QRM and related processes, increasing speed and efficiency while meeting regulatory requirements

Providing ongoing collaboration, engagement, and education to cross-functional teams for sustainability, compliance and effectiveness of the QRM system

2+ years experience building, leading and developing teams within quality systems

Provide support to the management system programs to ensure regulatory requirements and compliance activities support pipeline operations.

Degree, certification, diploma in Engineering, Project Management, Business, Economics, Environmental Science or other related disciplines.

Extensive knowledge of the Canada Energy Regulator (CER) requirements and processes.

Manage, track, resolve, and closeout regulatory compliance verification activities (e.g. audits) and coordinate compliance filings in a timely and accurate manner.

Effectively and efficiently manage regulatory applications, filings or submissions relating to operation activities.

A minimum of 10 years of experience in regulatory roles or equivalent.