Senior Manager, Regulatory Resume Sample
Al Spencer
553 Orn Pine,
Philadelphia,
PA
+1 (555) 590 6293
Work Experience
Manager / Senior Manager, Regulatory Systems
04/2018
-
PRESENT
Dallas, TX
- Create/Maintain Head Office Internal Policies and Procedures for Portfolio Aid
- Create/Maintain External Policies and Procedures such as Branch
- Creates, evaluates, and completes International regulatory projects consistent with the company goals
- Responsible for assembling regulatory submissions and international dossiers to non-EU territories
- Develop and implement regulatory strategies to facilitate the progress of global expansion of the company’s marketed products
- Serve as the Regulatory Affairs representative on internal and external project teams; assuring the progression of projects by providing strategy, and feedback to the teams
- Work with project-specific subject matter experts to successfully interact with international partners and global health authorities, including meeting preparation and communication of commitments and meeting outcomes
Senior Manager, Regulatory Strategy
03/2014
-
10/2017
Chicago, IL
- Manage meetings with marketing partners, and vendors for products/projects
- Support the company's commercial products, as necessary
- Maintain awareness of and communicate within the organization changing requirements across the international regulatory landscape (especially with respect to non-EU, emerging markets), updates for regulatory intelligence, and provide regulatory training
- Represent the company in external forums
- Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
- Previous experience with global regulatory filings (i.e. Canada, EU, Middle East, Asia-Pacific and South/Central America)
- Proven track record of effective collaboration with third parties/partners and regulatory agencies to obtain market clearance in other countries
- Demonstrated success in management of regulatory activities
Senior Manager Regulatory Supervisory Analytics
05/2008
-
01/2014
Los Angeles, CA
- Experience with regulatory agencies and preparation of documentation to support interactions
- Lead health authority interactions
- Knowledge and experience in preparation of global regulatory strategies
- Experience with maintenance of regulatory authorizations and variations in at least two regions
- Experience working on cross-functional development teams (including Commercial and R&D personnel)
- Maintains awareness of legislation affecting assigned business(es) and assists staff in assessing applicability and impact of new or proposed legislation
- Ensures that there is an appropriate source(s) of legislative information to cover the business area assigned
- Manages a team tasked with executing the regulatory change process and is responsible for ensuring their compliance with department procedures and associated timeframes
Education
University of Phoenix - Nashville Campus
2003 - 2008
Bachelor's Degree in Business
Professional Skills
- Strong computer skills - experience with : MS Office and document management systems
- Excellent organizational and time management skills, ability to manage multiple complex projects
- Strong, open and transparent communication skills (verbal and written)
- Developed writing skills to complete forms, reports, and e-mail communications
- Exceptional presentation and written communications skills
- Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA stages
- Strong understanding of the U.S. Regulatory Landscape
How to write Senior Manager, Regulatory Resume
Senior Manager, Regulatory role is responsible for training, retail, communications, software, compliance, reporting, securities, credit, finance, automation.
To write great resume for senior manager, regulatory job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Manager, Regulatory Resume
The section contact information is important in your senior manager, regulatory resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Senior Manager, Regulatory Resume
The section work experience is an essential part of your senior manager, regulatory resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous senior manager, regulatory responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior manager, regulatory position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Manager, Regulatory resume experience can include:
- Reviews, and in some cases, approves written summaries and/or detailed requirements of legislative changes which are communicated to the businesses and used to facilitate implementation of new legislation
- Supports RC and FCC management in the execution of compliance risk management program and any related projects. For RC, updates compliance risk system of record with new regulatory obligations to facilitate the compliance detailed self-assessment process
- Biotech or pharmaceutical industry experience required
- Working understanding of the Basel III Framework rules for large internationally active banks and OSFI’s Capital Adequacy Guidelines
- Provides input to and is an active member of assigned governance or steering committee meeting
- Lead consultation with various Federal and State agencies during permitting
Education on a Senior Manager, Regulatory Resume
Make sure to make education a priority on your senior manager, regulatory resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior manager, regulatory experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Senior Manager, Regulatory Resume
When listing skills on your senior manager, regulatory resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical senior manager, regulatory skills:
- Provide the framework, insights and challenge to enable AMP management and the Boards to effectively optimise enterprise wide risks and opportunities; and
- Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
- Monitoring & reporting on AML / ATF
- Providing AML/ATF compliance support to the Wealth Management business units
- Overseeing the implementation of the enterprise AML/ATF Program across the Wealth Management business line
- Collaborate with applicable testing team to conduct periodic review and testing of the GWM compliance program to ensure compliance with regulatory requirements
List of Typical Skills For a Senior Manager, Regulatory Resume
1
Skills For Manager / Senior Manager, Regulatory Systems Resume
- Well-developed communication skills to convey potential risk situations and implications and provide training to mutual fund representatives
- Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment
- Prior experience in the metabolism or endocrinology therapeutic areas is desirable
- Successful completion of the Effective Management Seminar (within 30 months of hire)
- Experience in oil and gas industry
2
Skills For Senior Manager, Regulatory Strategy Resume
- More than 10 years’ experience in a regulatory and/or EHS management role in the upstream oil and gas industry
- Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development
- Assist and support with developing policies, procedures and best practices for Third-Party Risk Management (TPRM)
- Support the Director with the development and implementation of Scotiabank’s Third Party Risk Management Policy (OSFI Guideline B10) for GWM business lines
- Work closely with GWM business lines to proactively identity, assess, mitigate and monitor outsourcing risks while providing key oversight functions and program assurance
- Assist and support with developing policies, procedures and best practices for AML/ATF compliance
3
Skills For Manager / Senior Manager Regulatory Afffairs Resume
- Coordinate with business units on topical and emerging regulatory changes
- Support business units by responding to questions about regulatory matters
- Expert analytic and problem solving capability
- Responsible for the accuracy of management information and reporting submitted to compliance, business and/or functional areas
- Escalates any significant compliance issues and trends to RC/FCC management and (Regulatory Affairs and Policy (RAP) through reporting and ad-hoc, as needed
- Assist in the implementation of the TPRM program for GWM
4
Skills For Senior Manager, Regulatory & Audit Liaison Resume
- Participate in the TRPM re-design and project implementation organized by Scotiabank
- Support the Director with the development, implementation and documentation of Scotiabank’s AML / ATF risk management framework for GWM business lines
- Coordinate with GWM business units to develop, enhance/build and manage GWM compliance programs to comply with applicable regulations (OSFI Guideline E21)
- Make recommendations to help implement appropriate corrective actions and processes for any businesses that are non-compliant
- Maintain current knowledge of applicable regulatory requirements
5
Skills For Senior Manager Regulatory Risk Services Resume
- Acts as the Global AML/ATF Operations liaison (go-to-person) for audits (internal/external) that relate to all topics (systems, process, procedures) in relation to the unit’s operation as follows
- Knowledge of Basel II and Basel III, in particular Standardized and IRB/AIRB Approaches for Credit Risk, and OSFI’s Capital Adequacy Requirements (CAR) Guideline A-1 and Implementation Notes for IRB Institution
- Successful completion of the Conduct and Practices Handbook at the time of hire
- Successful completion of the Branch Manager’s Course at the time of hire
- Well-developed knowledge of CIBC internal and external regulatory risk policies, procedures and controls sufficient to ensure compliance to IIROC business (i.e. Know your client, disclosure, tied selling, soliciting securities)
- Well-developed knowledge of the IIS platform, sufficient to support risk activities and to provide coaching from a risk perspective
- Developed leadership skills to provide coaching and feedback to CIBC employees including DVPs, Retail Distribution Branch Managers, Financial Advisors and Financial Service Associates on IIROC compliance requirements
- Developed time and self-management skills sufficient to schedule, organize and complete work within established timeframes, while accommodating changing priorities
- Good working knowledge of Scotiabank Finance and Risk systems
6
Skills For Senior Manager Regulatory Supervisory Analytics Resume
- Fluency in English and French would be an asset
- Highly proficient in Excel, and Access and other MS Office suite products. Ability to quickly develop MS Access queries would be a great asset
- Knowledge of the UK and European financial crime regulatory environment (knowledge of the global environment preferable)
- Helps ensure compliance, operational risk controls in accordance with HSBC or regulatory requirements, expectations, standards and policies; and optimizes relations with regulators by addressing any issues
- Rare disease experience is desirable
7
Skills For Senior Manager Regulatory Development Resume
- Performs quality control reviews on staff assessments of new legislation
- Inventory of manual processes documented and established along with commentary regarding the plan to automate each item or rationale indicating why automation doesn’t fit into the strategic principles (i.e. resources better deployed elsewhere)
- Fast paced, quickly changing environment
- Non-physical and requires extended periods of time at the computer
- Occasional extended hours as needed
8
Skills For Senior Manager, Regulatory Promotions Resume
- Accountable for Regulatory management processes and associated documents
- Active participation in affiliated regulation review and advocacy
- Lead consent agreement negotiations with various Federal and State agencies
- Assurance oversight on regulatory and compliance issues
- Leadership ability within a team environment
- Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
9
Skills For Senior Manager, Regulatory Initiatives Resume
- Responsible for specified regulatory deliverables for multiple development programs, working with the Global Regulatory Lead, cross-functional stakeholders and regulatory sub team members, as needed
- Develop, drive and coordinate regulatory timelines, working closely with the Global Regulatory Lead and other key stakeholders
- As the Regional Regulatory Lead, serve as the main point of contact with regulatory authorities, and lead region-specific regulatory authority interactions
- Ensure compliance of regulatory strategies and submissions with current regulations and guidance
- Represent US regulatory affairs on global regulatory subteam, providing updates on US specific activities and any changes to guidelines that could impact development program
- Support Global Regulatory Lead for the molecule in developing strategies for new development projects and partnerships, as needed
- Identify and communicate potential risks associated with regulatory strategies
10
Skills For Senior Manager Regulatory Relationship Management Resume
- Prepare IND and NDA submissions including clinical trial applications, amendments, periodic safety updates, supplements, meeting requests, briefing packages, annual reports, etc. Assist in managing internal review and submission of these items
- Lead the coordination, preparation and timely submission of regulatory documents and responses to queries from authorities Lead the coordination, preparation and timely submission of regulatory documents and responses to queries from authorities
- Maintain regulatory awareness
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