Associate Regulatory Manager Jobs

Special Knowledge, Skills and Abilities:

Strong analytical skills and demonstrated problem-solving abilities

Good working knowledge of Company operations, processes, products and services Solid PC Skills, including Excel, Word, PowerPoint

Develops and implements regulatory guidance strategies for new and existing product and service offerings to meet business objective. (20%)

Strong interpersonal skills in order to interact professionally with Commission Staff, Industry Associations/Coalitions, internal departments and other external stakeholders as required.

Knowledge of current regulatory issues, rules and environment (Federal and State)

3-6 years of Financial Securities Industry Operations with strong risk-managements skills

Good stakeholder management skills - team player with good communication skills, able to work effectively within a team

Preparation and maintenance of MIS reporting to senior management

·       Reporting experience in CFTC, CSA, SEC rules and regulations and industry best-practices

·       Experience in Rates, FX, Credit and Equity asset classes

·       Working to ensure the accuracy and completeness of our swaps data reporting

Excellent project management and organizational skills and capability to handle multiple projects at one time

Providing regular updates to management (including preparing technology personnel for meetings with regulators) regarding the matters being handled

Demonstrated knowledge in financial services operations

Strong interpersonal skills with the ability to work collaboratively and with people at all levels of the organization

Strong written and verbal communication and interpersonal skills

Join the Mizuho team as a Regulatory Risk Manager!

3+ years of experience in project management for complex data requests

3+ years of experience partnering with stakeholders to understand requirements and translate into data insights

Ensure data governance best practices are developed and followed consistently in adherence to compliance and regulatory requirements.

3+ years of experience in critical execution of data requests with unclear parameters

Direct experience with BigQuery and python

Healthcare, Clinical Informatics, Banking, or Insurance experience

Promoting cross-training, knowledge management, and problem-solving across the organization.

5+ years of experience in program management, design, implementation or ongoing operations management

Experience in a client facing/vendor management role

Assist the Sr. Manager with project management for cross-functional initiatives.

(A bachelor's degree or commensurate 4 years of experience

5+ years of work experience in health insurance, consulting, healthcare, and operations

Regulatory experience in the cosmetic industry, with a particular focus of EU fragrance allergens is a plus.

IT Skills (Microsoft Office, SAP, etc.)

Analytical skills and understanding technical scientific information

Strong written and oral communication skills are required. Strong interpersonal skills are important for working in fast-paced and matrix driven environment

Gathering, generating, and managing technical fragrance information

Provide Regulatory guidance, and support, including but not limited to:

Meet with stakeholders to discuss program status and goals applying project management skills most effective for the given implementation

3+ years of project management experience or operational experience

Experience reading regulations and identifying operational impact

PMP and/or Six Sigma Certification

Track a diverse range of regulatory change implementations using designated tooling

Make recommendations to improve processes and tooling

EDUCATION, TRAINING AND EXPERIENCE REQUIREMENTS

• Provide research, interpretation, and summary of regulatory requirements relevant to regulated substances.

• Provide education and training on product compliance with regulations for sales, Client Development, and Business Development.

• Author CHT USA Safety Data Sheets to ensure full compliance with US and other country requirements.

o 5-7 years of industrial chemistry experience

o 2-3 years of regulatory experience preferred

Able to generate solutions and appropriately escalate to management

Minimum 3 years of law firm / in-house paralegal or regulatory compliance experience

Financial product and/or securities law knowledge is a plus

Strong analytical skills and meticulous attention to detail

Able to take initiative in learning and applying new skills

Coordinate responses to various information requests, including 3rd party, client, and investor requests related to various legal / regulatory topics

Support Free Trade Agreements program - perform qualifications for Free Trade and provide suggestions for cost savings opportunities

1 or more years of previous experience within Global Trade and/or Regulatory Affairs field

Good written and verbal communication skills

Experience with excel, VBA code, and SAP

Americans With Disabilities Act (ADA)

The ability to make an impact and shape your career with a company that is passionate about growth

Manage all the databases, as per local regulation (e.g. EudraCT European database and EudraCT number request, ClinicalTrials.gov)

If necessary, directly manage ethical/administrative submissions

Conduct with his/her direct Manager annual performance review for his/her staff and provide career development opportunities

Degree level education is a plus preferably in pharmacy, medicine, or biological sciences

Minimum of 3 years professional experience, including previous experience in Regulatory or Start-up functions at a local/country level

At least 1 years of hands-on experience in the submission of clinical trial applications

7. Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements.

2. Exceptional planning/organizational skills and attention to detail.

3. Strong verbal and written communication skills.

1. 1 year of clinical research experience preferred.

1. Prepare regulatory documents for new study submissions to the IRB and sponsor.

Track the status of new submissions and inform clinical operations of relevant updates for study activation planning.

2+ years of experience in a clinical research environment.

Perform initial and subsequent IRB submissions.

Create and maintain the Investigator Site File for all studies awarded to Pharmaron CPC.

Generate all essential documents (i.e., Form FDA 1572, Financial Disclosure Forms, etc.) for submission to sponsor.

Report deviations/violations and Serious Adverse Events to the IRB.

Ensure IND safety reports are submitted to the PI and IRB for review.

Provide training on eCTD publishing processes and requirements related to the preparation, publishing and life-cycle management of electronic submissions.

Providing Electronic Document Management System (EDMS) user support for team members.

Electronic Document Management System (EDMS)

Representing Reed Tech and address the client’s business requirements and needs.

Experience with DocuBridge and Veeva Vault RIM preferred.

Excellent Word and Adobe Acrobat skills required.

Excellent project management skills. Must be incredibly efficient while also exercising judgment in allocating limited resources.

1-2 years experience in the energy sector preferred, with some working knowledge of the wholesale markets.

Master our business by working across the organization (Operations, Energy Markets, Engineering) and use that knowledge in advocacy.

Excellent written and verbal communication skills, effectively distilling complex ideas. Comfortable with basic data analysis.

Graduate degree (e.g., J.D. or Masters Degree) strongly preferred, or equivalent experience, with 0-2 years of post-degree work experience.

Work with cross-functional teams, especially Energy Markets, to develop these communications.

Working knowledge of drug development and submission requirements

Proficient in Document management and RIMS (Veeva RIM Suite Preferred)

Maintain up-to-date knowledge of global standards and procedures for regulatory submissions publishing processes

Bachelors degree or equivalent experience required

Experience in managing day-to-day administration of regulated systems

Excellent written, verbal, and interpersonal communication skills

• Perform other related duties as requested.

• Provide support for requests for regulatory-related documentation and aid in resolution of issues requiring regulatory review/oversight.

• Aid in review of engineering requested product changes (ECR) for regulatory impact. Authorized to approve changes.

• Review product labeling to ensure compliance with registrations.

• Support external regulator or customer audits.

Strong sense of planning and prioritization, and the ability to work with all levels of management.

Ensure that CMC content is complete, well-written, and meets all relevant requirements.

Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP/quality investigations throughout development.

Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience also preferred.

Excellent interpersonal skills to communicate difficult concepts and persuade others.

Strategic thinking and strong problem-solving skills with outstanding attention to detail.

Base pay offered may vary depending on geography, job-related knowledge, skills, and experience.

Oversee all product certifications that include Kosher, NSF, SQF, etc.

Manage raw and pack supplier and material approvals to ensure safe, quality materials are always used.

Oversee the improve the regulatory claims and certification process for accuracy to support continuous processes and performance of BODYARMOR products.

4 years’ experience in Regulatory Affairs in the food or beverage industry required

4 years’ experience in Quality roles ideally in supplier quality or food safety in the food or beverage industry required