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Director of Regulatory Affairs

About NJOY:

NJOY is one of the largest independent vaping companies in the U.S. and a leader in the revolution against combustible cigarettes. With a clear mission to Make Smoking History, NJOY offers a range of electronic nicotine products for adult smokers and vapers looking for an alternative.

The brand was founded in 2006 and has continued to serve as a pioneer and thought leader in the vaping category. NJOY holds a contract with the National Institute of Drug Abuse (NIDA) to supply a standard research electronic cigarette for use in independent, government-funded clinical studies – a project with enormous potential in the United States and across the world.

Overview:
NJOY is looking to expand the team with a Regulatory Affairs professional experienced in CMC in pharmaceutical or medical devices applicable to NJOY’s product analysis and manufacturing related programs. This hire will support our existing team in the execution of NJOY’s regulatory programs and other scientific work as required. This role will work in close collaboration with other NJOY team members, external specialist and preferred providers, in driving key parts of regulatory programs.

Primary Responsibilities:

Contribute to regulatory strategies that expedite the preparation, maximize the probability of success, and mitigate risks for NJOYs submissions to FDA.
Ensure CMC-related regulatory requirements and strategy are understood by project teams.
Assist with a broad set of regulatory responsibilities that may be operational in nature.
Liaise with external experts and specialist suppliers to secure excellence in deliverables critical to project plans to meet agreed timing, cost, and standard of work.
Coordinate and support the preparation of responses to information requests from regulatory agencies.
Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables.

Minimum Qualifications:

Experience within FDA regulated products in the biotechnology, medical device, pharmaceutical, or life science consumer products organization(s) leading to premarket submissions with a track record of approvals.
6 years of experience in the biotech, medical device, or pharmaceutical industry.
Bachelor’s degree in a life-science/ analytical field or equivalent.
Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership.
Ability to thrive in a collaborative and fast-paced environment with a willingness to wear multiple hats when necessary.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Advanced in Microsoft Office products (Word, Excel, PowerPoint).
Ability to influence without direct authority.
Demonstrated ability to manage external vendors/consultants.
Ability to interact and effectively communicate professionally with all levels of the organization.

Preferred Qualifications:

Experience with tobacco products or Electronic Nicotine Delivery Systems (ENDS) is not a requirement but is a plus.
Master’s, or Ph.D. degree in a life-science/ analytical field or equivalent.
Track record of receiving FDA.
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented appropriate and clear and conclusions are adequately supported by data.

Senior Manager, Regulatory Relations

Scotiabank

Join the Global Community of Scotiabankers to help customers become better off.

In this role you will be assisting the Regulatory Relations Group and Bank stakeholders with the coordination of interactions with regulators. You will ensure all activities conducted are in compliance with governing regulations, internal policies and procedures.

Is the role right for you?

Champions a customer focused culture to deepen client relationships and leverage broader Bank relationships, systems and knowledge
Assists with coordinating interactions with regulators, including but not limited to:Assisting in providing U.S. oversight for regulatory examinations and be a central contact for regulators;Coordinating and managing events related to examinations and continuous monitoring, including negotiating scope and timing of reviews, monitoring requested data aggregation and coordinating and attending regulatory meetings with control functions and business unit personnel;Collaborating with U.S. Business Heads to provide guidance on regulatory matters and continually enhancing the framework to identify, assess, control, and monitor regulatory communication across the U.S. Operations;Monitoring the full lifecycle of identified regulatory issues ensuring that concerns are communicated and assigned responsibility; Maintaining the centralized repository where documents are stored and previous examination memos and reports are archived;Ensuring timely submission of all requested daily, weekly and monthly reporting to our regulators; and identifying risks arising from interactions with regulators and escalate as appropriate
Understand how the Bank’s risk appetite and risk culture should be considered in day-to-day activities and decisions.
Actively pursues effective and efficient operations of his/her respective areas, while ensuring the adequacy, adherence to and effectiveness of day-to-day business controls to meet obligations with respect to operational risk, regulatory compliance risk, AML/ATF risk and conduct risk, including but not limited to responsibilities under the Operational Risk Management Framework, Regulatory Compliance Risk Management Framework, AML/ATF Global Handbook and the Guidelines for Business Conduct.
Champions a high performance environment and implements a people strategy that attracts, retains, develops and motivates their team by fostering an inclusive work environment; communicating vison/values/business strategy and managing succession and development planning for the team.

Do you have the skills that will enable you to succeed in this role? We’d love to work with you if you have:

A Bachelor’s degree; MPA/MBA/JD a plus
At least seven years of experience at a regulatory agency such as the FRB, OCC or SEC, or in a similar position in the financial services industry, or a legal regulatory background
A detailed and in-depth understanding of financial markets, products and control functions
Strong written and oral communication, presentation and interpersonal skills to effectively guide internal partners
Strong planning and organization skills
The ability to work independently and effectively with both regulatory staff and senior firm personnel
Sound judgment in identifying risks in order to proactively escalate with relevant senior management
Demonstrated ability to operate at a strategic level
Professionalism, sensitivity, and discretion required
The ability to solve problems, multi-task and manage changing priorities
The ability to be a collaborative team player
Office productivity skills (Word, Excel, PowerPoint and SharePoint)

Manager, Regulatory Affairs – Cosmetics

Lavvan

Role Overview

The incumbent will monitor and provide Global Regulatory Affairs guidance and support on LAVVAN ingredients and products related to the cosmetics industry. They will represent LAVVAN on trade organization scientific committees and manage various regulatory support and compliance programs. The incumbent will lead MSDS management and global compliance.

Job Responsibilities

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

· Monitor and stay current with global regulatory activity with particular attention to potential impact on LAVVAN products and operations

· Continuously update R&D, Sales and Product Development team members with relevant regulatory information

· Provide regulatory updates and guidance as related to cosmetics and other products as needed

· Represent Regulatory Team at product development status meetings to provide regulatory support to other teams

· Ensure compliance with various global regulations, including GMP, California Prop 65 Compliance, etc.

· Provide regulatory support for Sustainability and Green Chemistry initiatives

· Assess impact and monitor progress of EU REACH Compliance to LAVVAN

· Assist and support Product Development with non-clinical safety data and clinical data for new product formulations.

· Serve as point person on various committees

· Prepare Regulatory SOPs and guidance documents as needed to support certification efforts

· Provide technical support to various markets

· Other duties as required

Manage Regulatory support programs, including but not limited to:

· Preparation and development of Master Library List for cosmetic products globally

· Review / Approve product label/artwork for products globally, including harmonization of global warning label requirements

· Manage regulatory formulation rework progress as needed

· Submit products to the (WERCS) Worldwide Environmental Regulatory Compliance for product UPC registration

· Other duties as required

Global MSDS or SDS Management, including but not limited to:

· Create and maintain an SDS (Safety Data Sheet) database for all cosmetic products

· Ensure compliance of product MSDS with global requirements

· Implement the update to GHS (Globally Hazardous System of Classification) format for MSDSs and ensure raw material GHS classifications are updated in R&D systems

· Maintain MSDSs at Poison Control and Chemical Spill Center, if required

· Other duties as required

Job Requirements

· B.SC. or M.SC. in Toxicology, Pharmacology, Biology, Chemistry, or another health-related field

· Master’s degree is preferred

· 5+ years of regulatory experience in cosmetic regulatory and consumer products

· Previous leadership experience in regulatory affairs is required

· Strong interpersonal skills and capable of working in a fast-pace and matrix environment

· Demonstrated experience with market analyses and leveraging market research to inform design decisions

· Proven ability to work cross-functionally with colleagues to bring products from concept to commercialization

· Strong working knowledge of US and international regulatory frameworks for cosmetics products

· Ability to think critically and problem solve, particularly with respect to identifying unknowns and collecting relevant information to solve dynamic and complex problems

· Ability to identify insights, and distil information into alternative solutions and recommendations based on logic

· Project and change management to handle multiple projects (small and large) with conflicting priorities and deliver projects on time with excellence

· Interpersonal savvy (work effectively and build relationships with senior management, leaders and a number of cross-functional teams) and ability to deal with sensitive issues

· Exhibit high professional standards and integrity and personal ethical conduct

· Works well under pressure, change and ambiguity

Regulatory Affairs Associate

Premier Brands of America Inc

Regulatory Affairs Associate I support the Director of Regulatory Affairs with activities necessary for general regulatory maintenance / surveillance of products in a timely manner.

Duties & Responsibilities:

Maintain and manage in-house stability program to support product proof-of-life and follow-up with individual labs and creating

annual reports.

Support all new product initiatives, including claim substantiation efforts, protocol development and regulatory research.

Assist with drug registrations with the FDA for existing products.

Maintain external regulatory portals such as WERCs & JUMP/QUICKBASE. Participate with internal audits and corrective action

reports.

Work with customers/suppliers/external labs to ensure overall regulatory compliance.

Monitor emerging State and Federal regulatory changes and identify solutions for compliance.

Develop SOP’s in accordance with the organizational practices and compliance

Assist packaging claims and with artwork approval process.

Work at the direction of the Director of Regulatory on other special projects as they arise.

Qualifications and Education Requirements

Bachelor’s Degree in Life Science related discipline

Minimum of 2 years work-related experience in FDA regulated industry or pharmaceutical industry experience within Regulatory Affairs and or Compliance.

Understanding of FDA regulatory requirements

Strong knowledge of Word, Excel, and PowerPoint

Excellent verbal, written communications skills

Strong attention to detail, convey information clearly, concisely, accurately, and effectively.

Excellent interpersonal skills necessary to establish and maintain effective working relationships

Strong team player, with the ability to multi-task and handle multiple priorities.

Good organizational and time management skills.

Other Support:

· Assist with activities necessary for the timely preparation for project deadlines

· May be required to conduct basic research and analysis, as required.

· Assist fellow coordinators, as required.