Manager, Regulatory Job Description

Manager, Regulatory Job Description

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Manager, regulatory provides regulatory assessments for proposed business and manufacturing changes related to approved pharmaceutical products in compliance with FDA guidelines.

Manager, Regulatory Duties & Responsibilities

To write an effective manager, regulatory job description, begin by listing detailed duties, responsibilities and expectations. We have included manager, regulatory job description templates that you can modify and use.

Sample responsibilities for this position include:

Proficient in Word, Excel, Powerpoint and Visio, or similar
Experience in a similar role from within an investment bank, with a good understanding of financial markets and various products
Proven change management experience within an Operations environment
Ensure that the firm is continuously in compliance with all regulatory rules and regulations
Lead activities for non-submission regulatory reporting on behalf of GRA, ensuring GRO is managing data according to agency requirements and internal processes
Assessment of changes in the operating environment
Development of regulatory communications
Identify risks requiring mitigation
Monitor, manage, and escalate significant risk issues
Develop and execute testing strategies

Manager, Regulatory Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Manager, Regulatory

List any licenses or certifications required by the position: RAC, PMP, FDA, US, ETL, UL, ISO13485, CTS, OHSAS, MS

Education for Manager, Regulatory

Typically a job would require a certain level of education.

Employers hiring for the 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, Technical, Chemistry, Business, Engineering, Education, Biology, Pharmacy, Finance, Graduate

Skills for Manager, Regulatory

Desired skills for manager, regulatory include:

Operations
Regulations
Products
Regulatory requirements
Commercialization
Drug development process
Excel
FDA
Guidelines
Systems and organization

Desired experience for manager, regulatory includes:

Gain expert knowledge and understanding of the operating environment
Execute on ad-hoc, non-routine requests
Knowledge of legislation around animal feed, feed manufacturing, labelling and marketing and animal remedies is essential
Experience of working in a feed mill or animal nutrition production environment is desirable
Knowledge or some experience with auditing a production facility is desirable
Oversee all initiatives impacting Abandoned Property and / or our internal business units, identifying and escalating all critical regulatory issues to avoid adverse impact to the bank and customers

Manager, Regulatory Examples

1

Manager, Regulatory Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of 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 manager, regulatory
  • Ensures compliant shipment of products through the maintenance of applicable inclusions, spreadsheets
  • Review ongoing changes in the AML CFT and associated compliance requirements / regulations and to carry out gap assessments recommend controls
  • Regulatory Intelligence and updating changes in the local regulations
  • Develop and implement training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulations
  • Monitor developments in international UDI regulations and provide updates to the UDI project team and Corporate Regulatory team
  • Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company and provides training as required
  • Ability to question the status-quo
  • Strong organisational skills, in order to meet tight deadlines
  • Sound understanding of regulatory change (Dodd Frank, EMIR, ASIC)
  • Develop, enhance and maintain the regulatory control framework for daily, weekly, monthly, quarterly and annual reporting functions
Qualifications for manager, regulatory
  • Oversee analysis of data to provide relevant information to business units and senior management for issue resolution and risk control
  • Ensure that project requests are initiated, sponsored and assigned as required
  • Manage Third Party Vendors to ensure agreed upon service levels are met all and applicable Bank standards and policies are followed
  • Multiple technology projects may be in progress simultaneously, requiring considerable interaction with various project team members on all aspects of each project, and extensive project documentation review
  • Local promotional and non-promotional materials per the local promotional / non-promotional review SOP, to check compliance with Shire standards for Global Safety Information requirements
  • Logistics and content for local advisory boards organized by Commercial and/or containing an element of commercial strategy
2

Manager, Regulatory Job Description

Job Description Example
Our innovative and growing company is hiring for a manager, regulatory. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, regulatory
  • Interfacing and working closely with cross-functional development teams, Regulatory Agencies and partners to accurately and efficiently deliver regulatory documents and regulatory guidance to remain in compliance with all FDA, other U.S and international requirements
  • Prepares and supports regulatory submissions (PMAs, 510(k)s , Design Dossiers, Technical Files, IDE, Notified Body Submissions, revisions/supplements, ) in a timely manner, meeting current regulations and guidance document requirements
  • Work with international standard setting organizations (JEFCA, Codex, ) to make sure specifications are adequate for T&L products
  • Compliance with (global) legal requirements by adherence to requirements of existing and new regulations and legislation
  • Coordinate with the Business Units and other areas of Corporate Accounting to incorporate new GL accounts, products, systems and other changes that impact regulatory financial reporting
  • Related market rules and regulations
  • Produce and own the procedure for renewal within WFS
  • Review and preparation of various banking regulatory reports, including the quarterly Call and FRY9C, FRYLP, FRY10, FFIEC 009, FRY6, TICs
  • Liaise with regulatory examiners and internal audit to ensure that all of their requirements with respect to their examinations, including the compilation of information with respect to the Entry Day, and/or First Day, Letter, are met with little or no exceptions
  • Ensure alignment on project approach and interpretation across manufacturing sites
Qualifications for manager, regulatory
  • You will have sound financial knowledge and understanding of RPC GAAP
  • To lead, on behalf of the Head of RMR, in monitoring qualification developments in a planned programme of activity against key criteria, ensuring that procedures and quality standards are maintained
  • Strong knowledge of banking and financial services
  • Bachelor's / Master's Degree and/or Ph.D
  • 8+ years of relevant experience in private/ wealth management banking
  • Knowledge of the requirements for electronic submissions to regulatory authorities
3

Manager, Regulatory Job Description

Job Description Example
Our company is looking to fill the role of manager, regulatory. 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 manager, regulatory
  • Partner cross-functionally with compliance, legal, finance, analytics, business, and product teams to interpret, communicate, and operationalize licensing and regulatory requirements
  • Develop and review ingredient statements, nutritional labels and artwork ensuring regulatory compliance-15%
  • Provide regulatory support to manufacturing, marketing, quality, research & development, sales, customer service, supplier’s, vendors, export customers and project teams as needed -35%
  • Provides structured guidance to development teams and business partners -20%
  • Draft department policy and protocols
  • Supports onboarding of new employees and provides ad hoc training to peers -5%
  • Represent regulatory and quality in cross functional project teams and lead cross functional initiatives -5%
  • Knowledge of Nutrient Content Claims and Health Claims, and usage of factual statements
  • Stays current on Regulatory activities and changes impacting our Brands
  • Other activities as needed to support Department/Corporate initiatives
Qualifications for manager, regulatory
  • Minimum Bachelors degree in a scientific discipline, , chemistry, biology, pharmacy
  • Candidates must possess excellent communications skills (both written and verbal), with strong technical and regulatory writing ability
  • Manages multiple, projects and direct medium to large staff teams
  • Demonstrates strong oral and written communication skills, particularly in report and proposal writing and preparing presentations for clients
  • Significant examination experience or knowledge with agencies including Federal Reserve System, Office of the Comptroller of the Currency, FDIC, Consumer Financial Protection Bureau, Bank of International Settlements, or equivalent
  • Minimum of 5 years of related experience within a pharmaceutical company, CRO or similar organization and with minimum of 2 years International/Global CMC regulatory experience in biologics and/or small molecule drug development and registration activities
4

Manager, Regulatory Job Description

Job Description Example
Our innovative and growing company is looking for a manager, regulatory. 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 manager, regulatory
  • Recommend business operations process improvements
  • Conduct regulatory risk assessment for products
  • Oversee the creation of any waivers to federal regulations regarding PTC
  • Establishes, fosters and strengthens relationships with regulatory authorities
  • Refine regulatory strategy as new data become available and re-assess as necessary
  • Develop and update contingency plans for issues that affect registration, regulatory compliance and continued lifecycle management of the product
  • Manage a money transmitter licensing program that balances our legal and regulatory responsibilities while maximizing business and product flexibility
  • Cultivate strong, working relationships with our state and federal regulators
  • Maintain money transmission licenses, including applying for and renewing licenses, handling, gathering, and updating sensitive corporate information, and submitting monthly, quarterly, and annual reporting to regulators
  • Coordinate and oversee state and federal regulatory examinations, and work with relevant internal and external teams to ensure satisfactory regulatory examination results
Qualifications for manager, regulatory
  • To work closely with internal stakeholders and coordinate the production of COREP and Stress Test reporting
  • Respond to Regulatory requests for information
  • Work with many areas of our business and requires a working level of understanding across a broad spectrum – Finance, Investor Relations, Engineering, Brand and Product Marketing, Customer Insights external 3rd party research, think tanks, academics and global bodies such as the OECD
  • Experience with telecom industry or other regulated capital intensive industry
  • A detailed-oriented individual with a “can do” attitude and ability to work in a team environment individually with minimal supervision
  • BS in Electrical Engineering, Physics, Chemical Engineering/Material Science or related engineering field
5

Manager, Regulatory Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of manager, regulatory. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, regulatory
  • Support the development of regulatory strategies for assigned vaccine products
  • Establish objectives and develop processes and procedures to ensure efficient workflow
  • Uses KPIs to establish control mechanisms and other improvement initiatives
  • Develop in-depth understanding of the disease and product to provide sound medical opinion
  • Approval of medical and regulatory content
  • Provide medical and regulatory training material
  • Provide medical and regulatory support for all marketing activities
  • Track regulatory changes &analyze it’s impact on business
  • Understand consumer behavior and integrate the same with fundamental science knowledge of the disease and product
  • Aid in developing consumer insights by integrating science and consumer behavior understanding
Qualifications for manager, regulatory
  • International Standardization Process for Electronic Industry
  • Demonstrable understanding of operational processes
  • Scientific knowledge sufficient to understand all aspects of regulatory issues
  • Finance experience is essential
  • Managerial experience within finance would be desirable
  • Performs all scheduled quality monitoring activities (including internal audits, management evaluations, inspections, supplier audits)

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