Regulatory Manager Job Description
Regulatory Manager Duties & Responsibilities
To write an effective regulatory manager job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Regulatory Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Manager
List any licenses or certifications required by the position: RAC, PMP, FDA, US, ETL, UL, ISO13485, CTS, OHSAS, MS
Education for Regulatory Manager
Typically a job would require a certain level of education.
Employers hiring for the regulatory manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Technical, Chemistry, Business, Engineering, Education, Biology, Pharmacy, Finance, Graduate
Skills for Regulatory Manager
Desired skills for regulatory manager include:
Desired experience for regulatory manager includes:
Regulatory Manager Examples
Regulatory Manager Job Description
- Work closely with team members to learn daily process such as net capital calculations, CFTC Seg and Secured reporting, weekly 15c3-3 Customer and PAB Reserve Computation and FRB Reports – TIC and FR 2004
- Assist with all aspects of the CM LLC & CMA FOCUS Report
- Escalate operational risk loss events, control deficiencies and risks that you identify to your line manager and the relevant risk and control
- Participate in business development and relationship management efforts
- Contribute professional articles to industry and regulatory publications
- Attend relevant advisory committee meetings, federal agency meetings, coalition meetings, press conferences, issue briefings, hearings
- Provide input for Federal Advocacy communications materials, as necessary
- Monitoring and tracking of Telecom proceedings before the CRTC and Industry Canada, key timelines and deliverables
- Develop and maintain a network of internal relationships throughout the company
- Duties will be variable depending on the nature of the projects to be undertaken
- Requires in depth knowledge of operational risk management processes for a significant, complex and/or large scale business
- Ability to track and coordinate large and complex processes
- In depth knowledge of Credit Card and Merchant Services processes and workflows preferred
- High degree of expert knowledge of Canadian Credit Card and Merchant Services regulations
- Working knowledge of Asset & Wealth management functions, compliance regulations general knowledge of risk and controls
- Manage the preparation and perform review of the Quarterly and Annual
Regulatory Manager Job Description
- Participate in industry meetings/working groups for UDI as required
- Support UDI project team on all queries and requirements
- Creation and updates of Regulatory Standard Operating Procedures (SOP) for UDI requirements and identify and assist in the other departmental/ site SOP updates
- Prepare SOPs and guidance documents as required
- Provide input for preparation of the department’s budget
- Perform all other related duties as directed by supervisor and management
- Act as a contact with regulatory agencies in fulfilling local marketing authorisation obligations
- Provide regional input to & execute regulatory strategies
- Overseeing the work and day-to-day activities of Regulatory Affairs staff, including training, mentoring and ensuring professional development
- Recruit, develop and manage regulatory professionals
- Candidate must have a thorough understanding of regulatory change management and international renewals requirements (e.g., CHMP compliance assessment), possess a strong working knowledge of FDA/EMA regulations and other global authorities' CMC registration requirements
- Builds on client relationships through regulatory solutions offerings
- Leads as a subject matter expert internally and to clients in regulatory risk management and compliance
- Designs and implements business strategies or risk, compliance or operational transformations for systemically significant financial institutions, financial holding companies and large complex banks
- Capably applies strong finance, risk assessment and technology skills to develop solutions to regulatory challenges, including new and evolving requirements
- Contributes to team execution capabilities
Regulatory Manager Job Description
- Interface with Regulatory Agencies for inquiries and issues
- Review and maintain regulatory documents and files (including product label, promotional materials, manufacturing change requests, and registration packages)
- Support submission/filing projects and implement strategies to address issues throughout the filing process
- Coordinating implementation of regulatory policy in compliance with company
- The wider review of Embedded Benefits
- Implementation of the CMA recommendation for locational transmission losses
- Assure all marketing, sales and other materials
- Regulatory Resources
- Communicates with and advises development teams on publishing requirements, maintaining focus and awareness of potential delays, problems, gaps of information, expectations, project steps, milestones and deliverables
- Keeps abreast of current US and international regulatory practices, procedures and changes, as appropriate by project
- MS or PhD in EE, Physics, Chemical Engr/Material Science or related engineering field
- Fundamental EMC / RF concepts
- Global product regulatory knowledge inclusive of EMC / RF engineering related to multiple industries
- Experience in global product ecology (RoHS, WEEE, REACH) material content regulations
- Functional Safety standards for electronic products
- Medical Safety standards for electronic products
Regulatory Manager Job Description
- Coordination with Q&R team on the deliverables and perform gap analysis, preparation/review of document packages (CSDT) or the pre-market regulatory submissions locally and if required, regionally
- Prepares/review and submits Field Corrective Action reports and adverse event reports to the local competent authority, ensure the closure is obtain from the competent authority, if required, including any additional communications to local competent authorities
- Support and maintain the local/regional Quality Management System(s) (policies, procedures, work instructions), with revisions and implementations of new PHC and/or regional policies and processes
- Assist and participate in local/regional internal audits observing and assisting in the preparation for sector audits
- Ensure the CAPA is closed on time
- Assist with effective and efficient design and execution of control processes
- Assist with the identifying and reporting metrics associated with control processes and key risks
- Oversee control processes through periodic spot checks and audits
- Identify performance problems, developing plans for remedial action and evaluating performance
- Recommend changes to organizational policies and procedures
- Able to complete forms, use existing form letters and conduct routine oral communication
- Able to compose letters, outlines, memos and basic reports, and to orally communicate technical information
- Bachelor’s degree in Biochemistry, Molecular Biology, Immunology or Pharmacist with a total of 10 years industry experience with a minimum of 3 years in RA
- Additional training in Regulatory Affairs (e.g., Graduate or Certification programs) preferred
- At least 10 years experience in a Biological regulated industry
- Experience with IND, BLA submissions and updates/amendments to established licenses (PAS, CBE301) working/communicating with health authorities (FDA, EU IVD, ISO)
Regulatory Manager Job Description
- Support the CP regulatory organization with the coordination glyphosate dossier compilations
- Participate and represent Regulatory on New Product Development and Product Support Teams
- Adheres to the Guiding Principles
- Oversee, coordinate, and prepare regulatory study start-up documents and maintenance of protocol submissions to internal and external governing bodies
- Assists with the development of standard training requirements and assists with ongoing regulatory-related education and training for
- The Manager will be a key resource in preparing leadership for interaction with various stakeholders, including audit oversight regulators and policymakers in facilitating messaging on regulatory policy developments
- The global exposure will facilitate a deep appreciation for diverse cultures and cross border mechanisms to further globalization and convergence of regulation
- Attend meetings with Regulatory leadership, take notes, and provide briefings and other support to execute agreed-upon action items as needed
- Day to day supervision of assigned staff in order to develop, prioritize and manage multiple projects and budgets to maximize asset utilization and cost control within project(s) scope and approved budget
- Oversee CN’s PTC system certification required by 49 CFR 236.1015(a)
- Ensure fulfillment of the commitments in terms of timeline, quality of work, especially for registration projects, reimbursement and portfolio management
- Work to maintain marketing products registered without any risk to the business
- Work and provide its support and expertise to cross-functional
- Maintain compliance to group policies and local regulatory requirements
- On time new product registration
- Change of Registered Particulars / Variations / Labelling updates