What are the responsibilities and job description for the Sr. Regulatory Affairs Manager position at Roquette?
The products and solutions developed by the Group deliver proven technological, nutritional and health benefits precisely tailored to the pharma, nutrition, food and selected industry markets.
Roquette's offer is produced from plant-based raw materials such as corn, wheat, potatoes and peas.
Since its foundation over 80 years ago, the Group's growth has been based on innovation, a passion for the job and a commitment to achieve.
Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients.
Want to help us make a difference?
Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients.
Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles.
The Role:
We are seeking a dynamic and experienced Senior Regulatory Affairs Manager within our Regulatory Affairs team. The ideal candidate will have a strong background in regulatory frameworks for food ingredients and additives in the USA and Canada. This role will be instrumental in developing regulatory dossiers, ensuring compliance, and supporting market expansions of our innovative products across the food, animal feed, and plant care industries.
This hybrid position is located in Geneva, IL 2-3 days per week.
Compensation:
The current salary range for this role is estimated to be $100,000-$134,100. In addition, this position may also be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, and location.
What We Offer:
A highly collaborative team environment with ample room for exponential career growth.
Competitive pay, annual performance bonus, comprehensive benefits, 6.2% company retirement contribution, and professional development opportunities.
Generous paid time off and 12 annual paid company holidays.
12 weeks 100% paid maternity leave, and up to 4 weeks 100% paid parental leave (including adoption/surrogacy/foster care leave) for non-birthing parents.
Student loan repayment assistance and tuition reimbursement program for select roles.
Annual wellness benefit and wellness centered programs focused on your health needs.
What You’ll Do:
Organize and lead activities needed to develop regulatory dossiers to support new products and expanded uses of existing products for Roquette in the areas of food ingredients, industry uses, animal feeds, and plant care.
Act as an active partner to Quality Assurance team, providing necessary support to Roquette quality systems, including change controls, process improvements, consultations on raw materials and processing aids.
Review and interpret regulatory requirements applicable to product lines covering the United States and Canada.
Define efficient and cost-effective regulatory strategies to ensure successful market expansions for Roquette products.
Prepare regulatory submissions to ensure accuracy and completeness of documents, including meeting agendas and minutes, briefing packages for internal programs, and agency communications.
Maintain an organized inventory of all submissions.
Provide regulatory assessments and support to daily customer compliance requests, including creation of customer-facing regulatory statements and documents.
Implement tools and databases designed for regulatory operations and process improvements.
Draft, maintain, and update regulatory guidelines and positions for the region.
Support the Regulatory Head on complex problems where analysis of situations or data requires in-depth evaluation of various factors.
Monitor the external environment and keep Roquette advised of emerging regulation changes in the region.
Represent Roquette at trade associations and work proactively to ensure trade association efforts and activities are aligned with Roquette’s goals.
What You’ll Need:
Education:
Bachelor’s degree in a technical field such as food science, nutrition, chemistry, pharmacy, or related field.
Experience & Leadership Competencies:
Minimum of 5-7 years of experience in a regulatory/quality environment.
Demonstrates determination to gather facts and data from all available sources and use them for timely decision-making.
Favors simple and concrete actions in the decision-making process.
Takes initiative and focuses on finding solutions within the scope of responsibilities.
Capable of assisting others in making decisions when necessary.
Quickly seizes multiple situations and complex problems and makes robust, fact-based, timely decisions.
Maintains the quality of decisions under pressure.
Pays attention to explaining decisions to impacted stakeholders, even under tight deadlines.
Business Travel:
Up to 5% domestic travel required to meet business needs.
Occasional international travel may be expected.
AAP/EEO Statement
Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. “AAP, EEO, Drug-Free Workplace”
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
If you identify yourself in this position, please apply by uploading your resume and let's start the journey together !
Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences.
Roquette believes Diversity, Equity and Inclusion must be woven into everything we do, from the products we make, through the relationships we build with our partners, and most importantly within the teams we create and how we interact together.
As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach, by creating a workforce that represents the world we live in, and the communities and customers we serve.
To find out more about our products, values and sustainable development ambitions visit us at www.roquette.com and at www.sustainability.roquette.com
Salary : $100,000 - $134,100
