Regulatory Affairs Project Manager Job Description
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:
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:
Desired experience for regulatory affairs project manager includes:
Regulatory Affairs Project Manager Examples
Regulatory Affairs Project Manager Job Description
- 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
- 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
Regulatory Affairs Project Manager Job Description
- 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
- 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
Regulatory Affairs Project Manager Job Description
- 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
- 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)
Regulatory Affairs Project Manager Job Description
- 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
- 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
Regulatory Affairs Project Manager Job Description
- 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
- 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