Associate Manager, Regulatory Submissions Job at Altria
Overview:
We are currently seeking an Associate Manager, Regulatory Strategy Submissions to join our team in Richmond, VA. or we are open to remote work arrangements.
This position is responsible for the coordination and oversight of product regulatory pre-market submissions. This position will also resolve wide-ranging issues related to existing pre-market submissions for their category and develop new processes for implementation of such strategies.
In this role, you will:
We want you to have:
In addition to the opportunity to apply and develop your skills toward key strategic objectives, we offer an excellent compensation package including a driven base salary, comprehensive health/vision/dental insurance, participation in our deferred profit sharing and incentive compensation programs as well as a relocation assistance package. Company Overview: Altria has a leading portfolio of tobacco products for U.S. tobacco consumers 21+. Our tobacco companies – which have been the undisputed market leaders in the U.S. tobacco industry for decades – include some of the most enduring names in American business. In combustibles, we own Philip Morris USA, the maker of Marlboro cigarettes and John Middleton, manufacturer of Black & Mild cigars. Our smoke-free portfolio includes ownership of U.S. Smokeless Tobacco Company, the maker of Copenhagen and Skoal, and Helix Innovations, the maker of on! oral nicotine pouches. Additionally, we have a majority-owned joint venture with JT Group, Horizon Innovations, for the U.S. marketing and commercialization of heated tobacco stick products. Through a separate agreement with Philip Morris International, we have the exclusive U.S. commercialization rights to the IQOS* Tobacco Heating System® and Marlboro HeatSticks® through April 2024. Our equity investments include Anheuser-Busch InBev SA/NV, the world’s largest brewer and Cronos Group, a leading Canadian cannabinoid company. Each Altria company is an equal opportunity employer. We are committed to providing individuals with criminal records, including formerly incarcerated individuals and individuals with conviction records, a fair chance at employment. Learn more about Altria at www.altria.com and follow us on Twitter, Facebook and LinkedIn
Lead and coordinate pre-market submissions for a Fortune 200 Company with some of the most iconic brands! Do you have a Bachelor’s degree and five plus years of work experience in regulatory agencies, legal and compliance organizations, research and product development, or regulatory affairs? If so, we want to speak with you!
We are currently seeking an Associate Manager, Regulatory Strategy Submissions to join our team in Richmond, VA. or we are open to remote work arrangements.
This position is responsible for the coordination and oversight of product regulatory pre-market submissions. This position will also resolve wide-ranging issues related to existing pre-market submissions for their category and develop new processes for implementation of such strategies.
In this role, you will:
- Lead and coordinate the efforts of other group members to complete pre-market submissions to meet business objectives and timelines. Submissions include various submissions to receive pre-market authorization of new cigarette and/or cigar products
- Develop execution plans to meet new product strategies as defined by operating company and RA management
- Identify, analyze, and stay abreast of evolving state, federal and country regulations and apply knowledge required for submissions; implement plans to fulfill requirements
- Lead quality review activities for new submissions, including data quality, format, and content in compliance with FDA submission requirements and RA quality procedures
- Serve as a resource on regulatory reporting requirements for other departments and support compliance with regulatory requirements in a cross-functional manner to meet external compliance deadlines
- Communicate status/strategy updates to cross-functional partners and RA management
- Independently execute process and tools in support of regulatory submissions for their product category
- Evaluate regulatory documents (FOIA, FDA market authorizations or NSE/NonExempt findings) and disseminate pertinent information to cross-functional partners
We want you to have:
- Bachelor’s degree
- 5+ years of work experience in regulatory agencies, legal and compliance organizations, research and product development, or regulatory affairs
- Strong research, data analysis and interpretation skills and experience, ideally applied in a regulatory environment
- Strong interpersonal communication and relationship management skills with proven ability to meet goals and timelines
- Strong verbal and excellent written communication skills and experience including development of and delivery of communication documents and protocols
- Strong organization and planning skills and experience
- Position requires limited travel to manufacturing facilities and to various business meetings and forums.
In addition to the opportunity to apply and develop your skills toward key strategic objectives, we offer an excellent compensation package including a driven base salary, comprehensive health/vision/dental insurance, participation in our deferred profit sharing and incentive compensation programs as well as a relocation assistance package.
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