Regulatory Affairs Project Manager Job Description
Regulatory affairs project manager
provides regulatory input and direction to the Canadian Cross Functional Team and Global Clinical and Regulatory teams to build strategies, deliver optimal Health Canada approvals (time and quality), maintain compliance and positively impact clinical trials’ and products’ potential and lifecycle in the Canadian marketplace.
Regulatory Affairs Project Manager Duties & Responsibilities
To write an effective regulatory affairs project manager job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory affairs project manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Interpret existing or new regulatory requirements as they relate to company products/operations and procedures, clinical studies, testing, records, to ensure ongoing compliance
May receive delegation to represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met
Well versed in SDLC/regulatory requirements
Interpret and apply regulatory requirements
Support Regulatory Sub-team operations, including facilitation of Sub-team and Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up
Develop global regulatory strategies for UDI implementation and maintenance to ensure regulatory effective dates are met and act as a direct liaison with regulatory authorities
Manage post market surveillance activities, , adverse event reporting and field corrective actions
Work closely with Quality Assurance and participate in internal and external audits communicating with regulatory officials, as necessary
Perform the position’s duties in a professional manner, supporting Ortho Organizers’ and HF Acquisition Co.’s Quality Policy
Restricted substances
Regulatory Affairs Project Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Affairs Project Manager
List any licenses or certifications required by the position: PMP, RAC, II, PMI, CMDCAS, F202, CE, CCRA, CCRC
Education for Regulatory Affairs Project Manager
Typically a job would require a certain level of education.
Employers hiring for the regulatory affairs project manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Chemistry, Science, Medical, Pharmacy, Technical, Biology, Pharmacology, Microbiology, Math
Skills for Regulatory Affairs Project Manager
Desired skills for regulatory affairs project manager include:
Policies and guidelines
Canadian regulatory environment and Health Canada regulations
Oncology
Business functions and cross group dependencies/ relationships
Guidance
Particularly for new medicines in development
Regulatory requirements
Science
Various technical alternatives and their potential impact on the business
Worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these
Desired experience for regulatory affairs project manager includes:
Excellent written and verbal communication skills to include interacting with both internal personnel and external organizations (regulatory authorities, customers, distributors)
Bachelor / Master in medical/technical
Lean Sigma certification preferred
Advanced knowledge of MS Office products (Word, PowerPoint and Excel- formulas, pivots)
Track project deliverables through appropriate tools and framework
Some hands-on experience in Regulatory Affairs, or a combination of an advanced degree in Regulatory Affairs and relevant practical training in the field, is required
Regulatory Affairs Project Manager Examples
1
Regulatory Affairs Project Manager Job Description
Job Description Example
Our company is searching for experienced candidates for the position of regulatory affairs project manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory affairs project manager
- Role may have direct reports as projects develop
- Primary RA interface with Commercial
- Provide leadership and support to RA personnel in the affiliates (through ongoing communication
- Function as the Global Process Owner (GPO) for global regulations and Global Regulatory Council (GRC)
- Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management
- Lead small to mid-size global application projects - COTS, SaaS, Cloud, software selection and operations improvement initiatives
- Direct/participate in all phases of the project lifecycle - research, analysis planning, implementation, support and quality of new tools, technologies and or services
- Create and maintain comprehensive project documentation, including project timelines and budgets
- Direct supervision/mentoring of project team members, performance feedback to team member’s manager
- Compile
Qualifications for regulatory affairs project manager
- Relevant Project Management experience preferably within chemicals industry
- Proven record of working with multiple stakeholders in joint projects where communication and decision making are critical
- Effective communicator, active listener and excellent interpersonal skills
- 5+ years Medical Device Regulatory experience with pharmaceutical and/or medical device manufacturers
- 2+ years of experience in successful coordination and collaboration with cross-functional departments
- Minimum 6 years in project management required
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Regulatory Affairs Project Manager Job Description
Job Description Example
Our growing company is looking for a regulatory affairs project manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory affairs project manager
- May act as a Project Manager for a large stand-alone program, involving several regulatory or technical deliverables and/or region, and/or operation
- Establishes relationships with many customers
- Undertakes detailed review and management of budgets related to projects, including out of scope activities
- Manage Clinical Trial Notifications, TGA GMP clearances and AQIS permits
- Project manage artwork updates for Asia
- Track project deliverables including change controls through appropriate tools and framework
- Manage projects related to regulatory CMC deliverables and submission timelines as the primary responsibility
- Management of CMC submissions and follow up with Health Canada until final Health Canada regulatory decision
- Provide regulatory input to product lifecycle planning and in all stages of product development
- Depending on specific role, the Regulatory Affairs Project Manager may be involved in various regulatory activities (regulatory responsibilities for clinical trials
Qualifications for regulatory affairs project manager
- Consultancy skills and experience of working within a consulting environment
- Experience in registration and commercialization of medical device or diagnostic products
- Financial awareness and ability to actively utilize financial tracking systems
- Ability to present to staff at all levels
- International regulatory experience strongly preferred
- Ability to learn and stay abreast of regulations pertinent to medical devices
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Regulatory Affairs Project Manager Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of regulatory affairs project manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory affairs project manager
- Ensure submissions comply with applicable regulations and guidance documents
- Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
- Advises the plant sites to address issues that have regulatory implications
- Provides expertise in plant licensing basis, generic and plant-specific licensing issues
- Compile and submit drug master file for active pharmaceutical ingredients and other substances
- Provide input and comment on regulations and standards which may affect ADC products
- Compile and submit documentation for Annex II product certification and re-certification
- Supervising and coaching more junior RA team members located in The Netherlands and in India
- Mentor junior members of the Regulatory Affairs team
- Create and maintain Regulatory timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies
Qualifications for regulatory affairs project manager
- Solid knowledge of REACH and experience with European chemicals law (REACH and CLP)
- Knowledge of overall business environment
- Experience writing policies and procedures a plus
- Well-versed in program and project management
- Good working knowledge of and new product development best practices a plus
- Requires the ability to travel 10% of the time (domestic and international)
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Regulatory Affairs Project Manager Job Description
Job Description Example
Our company is looking to fill the role of regulatory affairs project manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory affairs project manager
- Filing and maintenance of Clinical Trial Applications (CTAs) with Health Canada
- Preparation of regulatory submissions and follow up with Health Canada until final Health Canada regulatory decision
- Health Canada requests
- Act as a liaison with department and outside department personnel to fulfill project/departmental goals
- Review deliverables prepared by team before passing to other cross-functional teams
- Request, compile, and file appropriate regulatory documentation for product information files
- Act as a liaison between consultants and the Regulatory team to ensure all invoices are paid in a timely manner
- Minimize exposure and risk on regulatory projects
- Compile, prepare, review and submit global pre-market and post-market regulatory submissions (including PMAs, IDEs, HDEs, ) to authorities
- Work closely with all members of the team in managing general regulatory projects
Qualifications for regulatory affairs project manager
- Experience with IOLs/implants highly desirable
- IDE submissions and PMA submissions for US
- Ability to draft and assess regulatory strategies for US market
- Strong business acumen, project management and solid communication skills
- Ability to write IDE and PMA submission documents without supervision
- Ability for work and collaborate with local and global cross functional teams
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Regulatory Affairs Project Manager Job Description
Job Description Example
Our company is growing rapidly and is hiring for a regulatory affairs project manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory affairs project manager
- Responsible for identifying areas within the company that require Regulatory Affairs Project Management to improve the company's compliance to regulatory requirements
- Leads in the understanding and awareness of US, EU and other international regulatory requirements to ensure compliance
- Maintain proficiency on quality and regulatory requirements
- Provide guidance on regulations and policies to project teams
- Comply with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments
- Support life-cycle management prescription and non prescription medicines, medical devices and cosmetics
- Submissions of variations/archiving
- Text translations/updates
- Artwork management
- Manage multiple projects while ensure timely completion of tasks and overall completion
Qualifications for regulatory affairs project manager
- A degree in chemistry
- Experience with working in international corporate and matrix organizations
- Experience in US FDA panel meetings
- Ability to communicate and interact with regulatory agencies and consultants
- Solid understanding of US clinical trial requirements and process a plus
- Solid project management skills, follow-through and hands on approach