Regulatory Affairs Documentation Specialist

Shelby American, Inc.; Bedford (MA); Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative company is seeking a Regulatory Affairs Documentation Specialist to join their dynamic team. This role involves managing and preparing essential regulatory documentation for product registrations, ensuring compliance with EU regulations for biocides and pesticides. The ideal candidate will have a strong background in regulatory affairs, with the ability to navigate complex documentation processes and collaborate with various internal departments. This position offers the chance to be part of a forward-thinking organization dedicated to delivering impactful products that enhance outdoor experiences. Join a passionate team committed to excellence and innovation in the regulatory space.

Benefits

Paid Time Off

Flexible Working Hours

Annual Target Bonus

Health Insurance

Pension Benefits

Birthday Off

Company Shutdown Period

Competitive Salary

Professional Development Opportunities

Remote Work Flexibility

Qualifications

• 2-5 years of experience in regulatory affairs for biocides and pesticides.
• Strong knowledge of UK and EU biocide regulations.
• Experience in preparing regulatory dossiers for EU market.

Responsibilities

• Manage regulatory documentation for product registrations and compliance.
• Collaborate with internal teams to ensure regulatory requirements are met.
• Assist in preparing for audits and inspections by EU authorities.

Skills

Regulatory Affairs

Biocides Regulation

Pesticides Regulation

Documentation Management

Data Analysis

Technical Writing

Communication Skills

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Environmental Science

Bachelor's degree in Chemistry

Tools

ECHA database

R4BP

Document Management Systems

Job description

All Jobs > Regulatory Affairs Documentation Specialist

Regulatory Affairs Documentation Specialist
Fully Remote • Remote, GBR

Description

Disclaimer: Please note, if you are selected to have an interview with Thermacell, you will receive an email from our applicant tracking system Paylocity ([e-mail]) or an email from a Thermacell.net domain. Be aware of phishing emails/text messages. Thermacell will never text or Skype you about your candidacy or personal confidential information. If you are unsure, please contact [e-mail].

THE COMPANY

Thermacell Repellents, Inc. is a privately held company with a mission to liberate people who love the outdoors from the harmful effects of insects. Founded in 1999 and based outside of Boston in Bedford, Massachusetts, Thermacell makes the world’s leading zone mosquito repellent protecting people and pets up to 20ft in outdoor spaces without sprays, scents, or chemicals on your skin.

Dedicated to delivering the best consumer experience, we have an ever-expanding product line for both adventure and home use. We aim to change the way people repel insects, through our award-winning science backed products, disruptive innovation, and expanding distribution across multiple retail & e-comm channels in over 30 countries across the globe.

Thermacell currently employs 125+ full time employees at our 4 locations: Bedford Massachusetts (Corporate HQ), Buford Georgia (Manufacturing & Distribution), and Hampton Florida (Science & Research Center).

ROLE PURPOSE:

This role will be part of the Thermacell regulatory compliance team. This team is leading the way in expanding into new geographies and countries for Thermacell. Thermacell spatial mosquito repellents are the first to market outdoor spatial repellents in most countries where we operate. So we are innovative in the regulatory space as we work with authorities to register our products. The Regulatory Affairs Documentation Specialist will be responsible for managing and preparing regulatory documentation required for product registrations, renewals, and compliance within the United Kingdom and European Union (EU) for biocides and pesticide products. This role will ensure that all regulatory requirements for biocides and pesticides are met, in line with EU regulations such as the Biocidal Products Regulation (BPR) (EU 528/2012). The specialist will report to the Director of Regulatory Affairs and work closely with various internal departments (Chemistry, Entomology, Engineering, Quality, Supply Chain) to prepare accurate and timely submissions and ensure products meet safety, efficacy, and environmental standards.

STATUS: Exempt

WORKING HOURS: Typically, between 9-5pm EST M-F (open to some flexibility)

WORK LOCATION: Remote – Flexible within Northern Europe or United Kingdom

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Develops and controls documentation for products that are subject to regulatory approval
• Utilizing a controlled documentation system, maintains technical and non-technical documentation for regulated products or product components.
• Ensures information is complete and accurate and meets the requirements of applicable regulatory agencies.
• Extracts, analyzes and summarizes product information for submission to regulatory agencies or to fulfill other requirements internally and externally.
• Contribute to the database of global registration information on each product including file location of all studies. Such a database will allow others from the company to easily obtain data in your absence.
• Meet data requests promptly to support the European business.
• Maintain and manage all necessary regulatory documentation for biocides and pesticides, including technical files, safety data sheets (SDS), product labels, risk assessments, and studies.
• Assists with ensuring that all required studies (e.g., efficacy, environmental, toxicology, residues) are included in the submission dossiers.
• Review and update regulatory documentation as needed to ensure ongoing compliance with evolving EU regulations and guidelines.
• Collaborate with internal teams such as product development, toxicology, environmental sciences, and legal teams to gather necessary data for regulatory submissions.
• Assist with the maintenance of existing product registrations in Europe. Keep key TRI business partners informed of potential risks, opportunities, and likely costs.
• Provide input and support to the product management team in efforts to amend and develop TRI’s European product label manuscripts in keeping with business needs.
• Assist in the preparation for audits and inspections by EU regulatory authorities, ensuring that all documentation is up to date and available for review.
• Support the preparation of responses to regulatory questions or requests for additional data from regulatory bodies.
• Partner with supplier regulatory personnel to ensure smooth and rapid transfer of data and information as needed. Continue to build trust in these relationships.
• Contribute to product development efforts in identifying potential regulatory stumbling blocks in Europe and around the world.
• Conduct label development reviews for the European business to ensure that labels are compliant with our registration.

THE IDEAL CANDIDATE:

• Lives our core values of Drive, Ownership, Integrity, Teamwork and Evolution
• Authentic and personable, humble, smart
• Relentless work ethic juiced by results, not titles or activities
• Externally competitive, internally collaborative
• Highly resourceful. Hands-on and practical
• Chooses curiosity and a commitment to learning over being right
• Radically candid – always with positive intention
• Motivated by challenge, resilient in the face of setbacks or adversity
• Able to critically think and navigate within a variety of ambiguous situations
• Even keeled energy, brings calm to chaos, low drama
• Make impeccable agreements, delivers end to end results with excellence
• Makes high quality data-based decisions with autonomy
• Unquenchable thirst for learning and self-improvement
• Effective communicator meeting people where they are
• Manages multiple, complex, and competing priorities

COMPENSATION

Compensation for this position will include a competitive base salary and an Annual Target Bonus program-details provided separately. We are proud to offer a competitive & valuable benefits package that enables you to protect your health, your family, and your way of life. Insurance & pension benefits may vary slightly by country and will be provided to finalist candidates.

Paid time off for this position will consist of vacation benefits at a competitive level, paid holidays, a day off for your birthday, and a company shutdown period between Christmas & New Year’s Day.

WHY WORK HERE?

We are proud of our company culture – it’s the fuel behind our dynamic and buzzing community! Our people are authentic, competitive and compassionate. It’s truly a unique formula for success.

We believe in the virtuous cycle of thriving employees fueling a thriving business. We believe in growing great leaders and helping people to unleash their full human potential. We believe in creating a frictionless organization where clarity and empowerment to do the work that matters as fast as possible. We believe in making impeccable agreements and relentlessly tracking exceptional results and celebrating achievements together! We believe in creating inspiring impact everywhere we can in support of our mission where everyone can be a force multiplier.

OUR CORE VALUES:

• Drive – An optimistic can-do spirit, a passion to delight our consumer, a belief in the importance of determination and the freedom to make a difference.
• Ownership – We are empowered to take accountability for our contributions and desire to do the highest quality work with responsible urgency to drive business results.
• Integrity – We will always do the right thing guided by truth and sincerity. We exercise constructive candor and have the willingness to challenge and be challenged in all interactions.
• Teamwork – The belief that we is greater than me, and with collective brainpower we are better together. We are a community of compassionate support and collective success. We win as one and play hard in celebration together.
• Evolution – We are committed to continuous improvement, always learning, growing, and adapting to constant change. We seek progress over perfection.

OUR COMMITMENT: Thermacell is committed to preserving a culture of diversity, inclusion, and belonging. The collective sum of our individual differences, knowledge, life experiences, and unique talents represents a significant part of our culture and is the foundation for our accomplishments and impact. We strive to create a supportive community where we all can show up as our authentic selves and are confident and comfortable to be genuine with our teammates in our day-to-day work environment. We are proud to be an equal-opportunity employer. We do not discriminate on the basis of race, color, religion, citizenship, national origin, sex (including pregnancy), sexual orientation, gender identity or expression, age, physical or mental disability, veteran status, marital status, genetic information, or any other characteristic protected by state, federal or local law.

OUR AWARDS: Popular Mechanics - Grand Award Winner - Recreation - Best of What's New 2018 New York Times Wirecutter - The Best Mosquito Control Gear for Your Patio or Yard Outside Magazine - Best Car Camping Gear 2018 Backpacker Magazine - Best Backpacking Accessory 2019 Field & Stream “Best of the Best” Award - Good Housekeeping Research Institute #1 Tabletop Mosquito Repellent – LIV Smart Mosquito Repellent System - CES TWICE Awards 2022-2021 - Canadian Tire Digital Excellence Award – CES New Tech Award – IDEA Good Design Award – Good Housekeeping Home Products Award - This Old House Editor’s Choice – Time Magazine Best Inventions 2022, Outside Gear Guide Editor’s Choice 2022, NYT Wirecutter pick for “The Best Mosquito Control Gear for your Patio or Yard” 2023, CNN Underscored Editor’s Pick 2024, Great Place to Work 2025!

Requirements

SKILLS/KNOWLEDGE/EXPERIENCE REQUIRED:

• Bachelor's degree in Life Sciences, Environmental Science, Chemistry, Agronomy, Toxicology, or a related field.
• Minimum of 2-5 years of experience in regulatory affairs or regulatory documentation for biocides, pesticides, agrochemicals, or related industries within the EU.
• Minimum of 2 years in Consumer Product Specific registrations.
• Familiarity with mosquito repellent and insecticide products for a minimum of 2 ears.
• Strong knowledge of UK and EU biocide and pesticide regulations, including Biocidal Products Regulation (EU 528/2012) and REACH.
• Experience in preparing and submitting regulatory dossiers for biocides and/or pesticides in the EU market, including data submission for efficacy, toxicology, and environmental risk assessments.
• Proven relationship skills with diverse personality sets and be able to gain the response and confidence of TRI’s senior leadership team, team members, and third party partners with their regulatory expertise.
• Proficiency in English (written and verbal); knowledge of additional languages is a plus.
• Experience with regulatory submission tools, databases, and document management systems (e.g., ECHA database, R4BP, or others).
• Maintaining aspects of regulated products—especially products regulated under the EU.
• Managing regulatory compliance or product registration efforts.