Regulatory Director Job Description
Regulatory director
provides senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of regulatory program management and regulatory requirements and guidelines, procedures and best practices.
Regulatory Director Duties & Responsibilities
To write an effective regulatory director job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory director job description templates that you can modify and use.
Sample responsibilities for this position include:
Understanding of core banking issues relevant to banking and bank regulation
Provide the General Auditor, management, Bank executive management, and the Audit & Finance Committee with appropriate reports/updates (written and verbal) regarding the results of audits and risk assessments
Manage the development and delivery of EMEA RRG management information including regulatory relations and regulatory response oversight information
Lead, mentor, and coach a regional team of regulatory professionals to drive strategic and effective public policy outcomes that support the needs of the marketing and product development teams
Serve on project teams to lend technical expertise during product or service development
Driving continuous improvements in quality and timeliness of regulatory financial reporting
Maintaining a high degree of knowledge of all current applicable accounting and financial reporting requirements
Effectively interfacing with and managing financial reporting information flows with other departments within the organization
Ensuring that new and complex transactions are properly accounted for and reported in the FERC and State regulatory financial reports
Liaise with the external auditors in connection with annual FERC financial statements that are subject to audit, including working with the Controller, Assistant Controller, Director of External Reporting and the external auditors to plan for the various audit requests
Regulatory Director Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Director
List any licenses or certifications required by the position: RAC, FEMA, CPA, RAPS, ASQ, CAMS, IV, TFD, ISO, FDA
Education for Regulatory Director
Typically a job would require a certain level of education.
Employers hiring for the regulatory director job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Engineering, Chemistry, Medical, Education, Business, Pharmacy, Biology, Life Sciences, Technical
Skills for Regulatory Director
Desired skills for regulatory director include:
Bank
Consumer lending organizations
Credit-related regulatory requirements
Industry “best practices” for compliance programs in larger banking
Specifically related to consumer compliance regulations
Applying regulatory standards and influencing regulatory changes through association and government interactions
Commitments and data to lead teams
Complex projects
Control summaries
Development
Desired experience for regulatory director includes:
Lead the coordination with various groups for the timely flow of information required for preparation of and disclosure in the regulatory financial statements
Work on the improvement and enhancement of communications and processes around obtaining information necessary for the production of regulatory financial statements
Organizational skills, including the ability to manage and coordinate multiple projects and other assignments at the same time
Knowledge of SAP, PeopleSoft and Oracle
Likely to involve some domestic and international travel
Responsible for overseeing the governance, implementation, execution and delivery of the I&TS Regulatory Business Endeavours Portfolio (the “Portfolio”) comprised of all active and pipeline programs, projects, enhancements and business initiatives involving a direct or indirect regulatory obligation on the part of I&TS and/or its clients (“Regulatory Business Endeavours”)
Regulatory Director Examples
1
Regulatory Director Job Description
Job Description Example
Our company is looking for a regulatory director. 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 director
- Must be able to file one or two new INDs per year and handle multiple active INDs concurrently contribute to multiple early stage (preIND) product development teams
- Leads development and delivery of general inspection training including sharing of inspection lessons learned
- Serve as the leading subject matter expert for complex regulatory reporting topics
- Stay current on new and changing IIROC rules to effectively interpret and apply the rules
- Proactively review and assess proposed business transactions and initiatives from a regulatory reporting perspective on an ongoing and continuous basis
- Create relevant documentation covering key/high-risk regulatory reporting topics including our policy choices, their margining and capital impacts for easy reference
- As part of the overall gatekeeper role for regulatory reporting matters, this role is responsible for developing and successfully implementing a strong control framework to support the accurate regulatory reporting of the above mentioned complex areas
- Communicate and oversee implementation of management's vision, goals and objectives regarding audit strategy, policies, and professional practices
- Lead the Audit program and enhancement, responsive to the OCC's heightened expectation
- Attract, recruit, and develop high caliber managerial and professional practices staff talent
Qualifications for regulatory director
- Must be able to execute on deliverables and work well under pressure
- Project management training, skills and experience are an asset
- Candidate should have 10-15 years of relevant work experience in the financial and/or consulting industry and extensive knowledge of Risk Management and Compliance principles
- Previous change management experience such as rolling out or implementing new solutions
- Experience at managing multiple stakeholders in multiple jurisdictions
- Be creative, self-starting, results oriented and highly motivated
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Regulatory Director Job Description
Job Description Example
Our company is growing rapidly and is looking for a regulatory director. 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 regulatory director
- Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and regulatory authority reviewers
- Ensure consistency/completeness/adherence to standards for all regulatory submissions
- Coordinate and consult with other departments on the content, review of publication and promotional materials, and assembly of regulatory documentation
- Represents Regulatory Affairs as a member of the cross functional project team(s) and provides regulatory input for the project(s) globally
- Develops and implements the US regulatory strategy for the project(s)
- Coaches and mentors Regulatory Affairs staff
- Work in close collaboration with the VP, Regulatory Affairs Americas and regional counterparts to integrate all aspects of US and global regulatory strategy
- Ensures timely compilation and transmittal of original INDs /CTAs/BLAs for new product candidates
- Lead interactions with regulatory agencies in both U.S. and globally
- Conduct regulatory intelligence/research related to AIRM products and to assist in formulation of strategic regulatory decisions
Qualifications for regulatory director
- Ensuring a good understanding of the relevant capital regulations for the jurisdictions where BAC has branches or subsidiaries, provide technical leadership in the evolving landscape, to drive a common understanding of where and why proposed regulations will impact the capital requirements
- Knowledge and practical application of stress testing would be advantageous
- Broad knowledge of market risk, credit risk, operational risk and financial products
- Strong quantitative skills and genuine interest in interpretation of data
- Such a partnership is also expected with the other business-aligned risk and controls managers, sharing the common goal of providing a well-controlled operating environment to maximize value to our shareholders
- Minimum 15 years of experience in public accounting, auditing, audit management, budget, business plan, business strategy, preferably with big Audit Firms, legal experience is a plus
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Regulatory Director Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of regulatory director. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory director
- Provide regulatory due diligence and regulatory advice for potential new product opportunities
- Communicate new regulatory standards pertaining to prescription drug promotion and advertising to brand teams and management, as appropriate
- Develop regulatory best practices, working instructions, SOPs for product promotional activities, to establish standards and consistency across products
- Develop and maintain relationships with other internal departments involved in the product promotion and communication process
- Work directly with the marketing teams from concept through review and approval, up to and including DDMAC/OPDP submissions
- Collaborates with other regulatory colleagues to provide input to study designs and target product label with regard to feasibility of promoting potential data/claims
- Oversee internal review and approval process to ensure that prescribing information is accurate, current and consistent with core labeling
- Maintain compliance for regulatory submissions
- Conduct proactive surveillance on primary and secondary sources of regulatory intelligence information, agency websites, databases, competitor websites, journals
- Engage closely with the Sr
Qualifications for regulatory director
- You have exceptional written and communication skills and experience owning high profile client relationships
- You have superb project management and communication skills
- You have experience working on cross-functional teams
- Bachelor's degree in (pharmacy, biology, chemistry, pharmacology) or related subject required
- Relevant advanced degree is preferred
- 7+ years’ experience in pharmaceutical regulatory activities preferred
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Regulatory Director Job Description
Job Description Example
Our company is hiring for a regulatory director. 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 regulatory director
- Communicating regulatory project status to internal stakeholders
- Interacting with and influencing external regulatory agencies and trade associations
- Evaluating risk and safety issues and recommend regulatory solutions
- Contributing to cross-functional, divisional initiatives
- Sponsoring and mentoring of associates
- Operational management of a US-based team, including financial and project-related management
- Effectively manages the team's resources and delegates tasks commensurate with skill level
- Effectively collaborate with operational colleagues to manage project- and team-related challenges
- Contributes to discussions on implementation of business strategy on a regional basis and will implement regional and global specific objectives, as appropriate
- Will have full financial responsibility and accountability for Regulatory Affairs sites
Qualifications for regulatory director
- Highly conversant and knowledgeable of new and emerging regulations and guidances
- A minimum of 12+ years experience in regulatory affairs
- Strong knowledge of US drug and biologic regulations ICH and US guidance documents
- Has a strong in-depth knowledge in the Regulatory field, along with a broad knowledge of related disciplines including clinical research, CMC, quality and nonclinical research
- A firm understanding of pre-IND to Phase 3 clinical study submissions for investigational new drugs/biologics including experience with preIND/EOP2 meetings, original IND filings and related amendments
- Ability to manage multiple projects/submissions concurrently a must
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Regulatory Director Job Description
Job Description Example
Our company is growing rapidly and is hiring for a regulatory director. 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 regulatory director
- Formulate & implement Regulatory plans to achieve efficient & competitive product development, working with regulatory senior management to define regulatory strategies
- Provide regulatory input into cross-functional Project Teams for product development and submission activities
- Provide regulatory review and approve of internal documentation supporting product development activities
- Monitor the development of new requirements or regulatory procedures
- Ensures compliance with all existing licenses or permits at a given facility by tracking licenses and permits or requiring a direct report to track them
- Provides technical support to the Communications team in drafting communications for the general public regarding regulatory issues
- Drafts, reviews, negotiates and supports approval of interconnection agreements under Sections 251 and 252 of the Telecommunications Act of 1996, and drafts and negotiates SIP traffic exchange agreements
- Supports the business unit on disputes arising from the traffic exchange agreements and provides support counsel on related litigation matters
- Provides support for various voice and broadband FCC and state regulatory matters and proceedings, including participation in drafting of comments and other filings
- Effectively advises the business on voice and broadband regulatory obligations and issues, and proactively works to limit compliance issues and potential liability
Qualifications for regulatory director
- Ten (10) years’ experience in Clinical Operations and/or other BI Medicine functions
- Strong interpersonal, cultural and communicational skills
- Technical savvy for capturing and analyzing information
- Experience as a strong regulatory advisor to regulatory professionals as a key member of the RST
- Awareness of current trends in regulatory affairs
- A thorough understanding, strong working knowledge, and previous experience applying medical device/IVD regulations of FDA and International regulations (ideally including EU, Canada, and Japan)