Senior Manager, Regulatory Job Description
Senior manager, regulatory
provides regulatory CMC guidance to the CMC project teams to ensure development activities are compliant with relevant guidelines and governmental regulations.
Senior Manager, Regulatory Duties & Responsibilities
To write an effective senior manager, regulatory job description, begin by listing detailed duties, responsibilities and expectations. We have included senior manager, regulatory job description templates that you can modify and use.
Sample responsibilities for this position include:
Prepare and provide oversight for submission dossier creation with respect to new products, renewals, product changes, advertising, and other licensing
Work with Global RA to develop and implement streamlined consistent processes for both new products and life cycle management
Advising Front Officers on changes implied by the regulations
Develop and execute global regulatory strategies specific to respiratory products
Interface with key internal stakeholders including Project Management, Clinical, Regulatory CMC, Devices, Pharm Sciences Teams and Regional Regulatory
Maintains expert level knowledge in the eCTD publishing, electronic document management software and relevant regulations for the preparation and maintenance of regulatory dossiers to Health Authorities
Responsible for validating the accuracy of the methodologies applied, parameters and data used in the capital engine for generating regulatory capital figures
Ensure that BCAR submission to OSFI and Head office are completed on time while respecting the approved attestation framework and reporting guidelines
Responsible for development and successful implementation of BCAR attestation framework
Take lead on ad-hoc projects undertaken to enhance existing and develop new capital measurement and reporting processes
Senior Manager, Regulatory Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Manager, Regulatory
List any licenses or certifications required by the position: RAC, CRCM, MDD, PMP, CPA, ISO, CIA, MDR, FDA, US
Education for Senior Manager, Regulatory
Typically a job would require a certain level of education.
Employers hiring for the senior manager, regulatory job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Chemistry, Engineering, Business, Biology, Pharmacy, Life Sciences, Finance, Technical, Accounting
Skills for Senior Manager, Regulatory
Desired skills for senior manager, regulatory include:
Operations
Products
Regulations
Systems and organization
Assigned businesses
Excel
Services
CMC
Labeling
Clinical development
Desired experience for senior manager, regulatory includes:
Private Bank (PB)
Strong regulatory reporting knowledge, including experience with FR Y9C, Call Report, FFIEC 009
Manages and fulfills on a timely basis a schedule of reviews of certain U.S. Compliance functions, in accordance with the Compliance Functional Instruction Manual (“FIM”), Sections B2.1.3, and CRMP Manual as directed by the Head of the department
Interacts effectively with all levels of the Compliance and business teams as warranted
Act as primary risk capital liaison with business units, internal audit, OSFI, corporate treasury, finance, model governance unit
Maintain current methodologies and documentation and participate in the development of new methodologies as regulatory requirements change
Senior Manager, Regulatory Examples
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Senior Manager, Regulatory Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of senior manager, regulatory. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior manager, regulatory
- Provides strategic labelling support to teams and generate labelling scenarios for products throughout their development and maintenance lifecycle
- Implement regulatory CMC strategies
- Preparing regulatory briefing documents and representing regulatory CMC in technical and strategic discussions with global Health Authorities
- Conduct regulatory assurance reviews of key areas identified via the annual risk and control self-assessment exercise, those requested by Compliance management or other areas within the Risk Management Group or the Business
- Current, PRA, FCA and BOE technical knowledge required
- Postgraduate / professional accounting qualification
- Strategic vision for the function with a desire to lead and guide others to achieve goals and objectives
- Co-ordinate with Legal and Central and Business Compliance on the development of compliance policies, processes and other responses
- Responsible for all relevant booking models aspects
- Work closely with CFM business BORMs and RMG Business Compliance on all the facets of SMR/Certified person's responsibilities reporting lines, suitability, appropriate MI being provided, trader mandates being adhered to, booking models, surveillance and monitoring, training, consequences management
Qualifications for senior manager, regulatory
- Lead the process to validate the results of the capital calculations with the business and manage the attestation process required by the regulators
- Assist the business by performing impact or scenario analysis of expected parameter or portfolio changes on capital requirements
- Axiom system experience desirable
- Good Regulatory Capital knowledge (+3 years)
- COREP/PRA Regulatory Returns knowledge desired
- Proven ability to perform ad-hoc analysis on complex datasets, draw out themes and key issues and communicate meaningful findings to senior management
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Senior Manager, Regulatory Job Description
Job Description Example
Our growing company is hiring for a senior manager, regulatory. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior manager, regulatory
- Provide support for all non-EMEA Regulatory projects to ensure CFM EMEA is compliant
- Undertake collective accountability and ownership for the design, development and execution of key compliance programs while ensuring a “Business Value Approach” is taken by enabling the “Change the Bank” and “New Initiative Onboarding Criteria and Projects” strategies
- Lead design working sessions with senior stakeholders, supports data analysis and presents design approach, options and decisions to key stakeholders and senior leaders informed by common design principles and balanced by change management considerations
- Drive change by optimizing and balancing risk, client experience and efficiency to drive toward more flexible and streamlined service delivery while enhance the client & sales experience
- Responsible for providing advice and counsel for operational efficiency and effectiveness, operational risk related issues and client care opportunities identifying root cause and solutions
- Instigates change with functional groups when status quo does not meet regulatory and/or business/clients’ needs, questioning redundant policies and building compliance requirements into applications permitting employees to remain focused on client advice and service
- Representing the Executive Sponsors, is responsible for development and execution of projects/initiatives, providing oversight management of all phases of project from idea creation to implementation, co-ordination of all associated activity in order to meet specific implementation schedules, through to project closure, ensuring that key stakeholders are kept informed through timely updates, progress reports and issue escalation
- Impact and influence Business Functions to improve Sales and Client experience, close operational gaps, ensuring initiative results are compatible with P&CB risk and compliance goals
- Assessing regulatory impacts for Global Markets
- Representing Global Markets in relevant group level committees and
Qualifications for senior manager, regulatory
- Maintain productive and credible long-term relationships with internal and external stakeholders
- Strong project management and team working skills, with proven results implementing projects (regulatory related preferred but not required) within a financial/trading environment
- Ensure effective roll out of policies and procedures
- A minimum B.Sc
- Contribute to maintain a central Global Markets repository of documents relating to each major regulation in scope
- Work closely with Global Markets trading and sales heads, GBLs and local Business Management and other internal business partners (Global Markets Regulatory Affairs, Compliance, Legal, GRM and ITO), and act as an key contact point where necessary on Regulatory aspects
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Senior Manager, Regulatory Job Description
Job Description Example
Our innovative and growing company is hiring for a senior manager, regulatory. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior manager, regulatory
- The end to end implementation of 1 or 2 major regulatory changes, notably by
- Lead the preparation of regulatory briefing documents and coordinate scientific advice meeting discussions with Regulatory Agencies’ Worldwide including US, EU, Canada, Japan
- Work with Regional Regulatory teams and take overall accountable for delivery of quality regulatory submissions MAA’s, NDA’s and ANDAs, INDs, CTAs
- Remain current with and be able to interpret Regulatory guidelines for US, EU and selected Rest of World territories
- Actively seek to assess and improve processes and procedures
- Influence the external environment through representation on relevant organisations, attendance and presentation at conferences
- Plans submissions to ensure timely submissions to Health Authorities, especially for annual reports, safety alerts and PADERs
- May represent Regulatory Affairs on project teams, driving timelines and deliverables related to submission to Health Authorities
- Reviews documents to ensure they comply with applicable regulatory eCTD guidelines and prepare paper and/or electronic submission documents for the Health Authorities
- Files regulatory submissions to Health Authorities and archive submissions in accordance with Acorda’s guidelines/SOPs
Qualifications for senior manager, regulatory
- Promote when relevant the standardization of practices across all Global Markets
- Extensive Regulatory knowledge (EMIR, MIFID, DAF…) experience gained in financial sector
- Proven project / programme management experience
- Able to communicate clearly and advise Global Markets top-management
- Interest in current regulatory developments
- Be client focus - Sees stakeholders external clients as “customers”
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Senior Manager, Regulatory Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of senior manager, regulatory. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior manager, regulatory
- Organize Project Team meetings and facilitate team of SMEs to address CMC questions from FDA, consolidating responses, timelines, and managing vendors
- Prepare,coordinate, manage, and/or maintain regulatory submissions (e.g.,INDs, CTAs, amendments, safety reports, DSUR/annual reports, meeting packages, ) in accordance with applicable regulations
- Trains Acorda teams to use the electronic publishing/viewing software
- Tracks and orders submission and equipment supplies
- Assists in creating, editing and revision of Regulatory SOP’s
- Assists in maintaining the electronic publishing system including upgrading software, validation documentation, related SOPs, training and retraining of system users
- Provides ongoing feedback, development and performance reviews of staff
- Responsible for training and mentoring associates in the Regulatory Affairs department
- This individual may supervise associates on the Regulatory Submissions team
- Take the lead and responsibility for complex CDS maintenance and development activities including the planning, creation of timelines and project management for CDS activities
Qualifications for senior manager, regulatory
- Solid network within Global Markets and functions
- Strategic thinking and analytical reasoning
- Team player willing and able to communicate efficiently with a global network of people (Global markets GBLs and functions, Group)
- Bachelor’s degree or equivalent in Pharmacy, Life Sciences or related field required
- Advanced degree (Phd, Pharm D or Master’s degree) in Life Sciences or related field preferred
- Minimum of five to seven years of filing regulatory electronic submissions to health authorities required
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Senior Manager, Regulatory Job Description
Job Description Example
Our innovative and growing company is hiring for a senior manager, regulatory. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior manager, regulatory
- Lead the development, implementation, and influence of CMC regulatory strategy, particularly for EU/GEM markets, identifying risks and mitigations and may represent Regulatory on project teams
- Provide support for other CDS-related activities and initiatives as required
- Support the implementation of CDS changes into the Local Product Labels (LPLs) and have involvement in tracking local label compliance and local label deviations
- Networks and shares best practices within and across functions to ensure efficiency and consistency across teams
- Provide competitive labelling comparisons as required for CDS preparation
- Support the Labelling Management team in the training of Program and Product teams on CDS policies and procedures
- Maintain an overview of relevant global regulatory labelling requirements
- Actively seeking to assess and improve processes and procedures
- Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards
- Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
Qualifications for senior manager, regulatory
- Experience with regulatory submission to Health Authorities is required
- Must have ability to handle multiple projects simultaneously and contribute effectively to project team functions and work flows
- Self-motivated Strong attention to detail Demonstrates sense of ownership and accountability for work
- Prior people leadership experience is a plus
- Problem solver - strong analytical capabilities
- Strong communication skills and ability to convey clear insight and thought leadership with strong presentation skills