Regulatory Manager
We are Reckitt
Research & Development
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
Your responsibilities
- Serves as a Business Partner by translating regulatory trends and requirements into business growth opportunities and establishing and maintaining proactive communication and constructive rapport with key partners across the organization to streamline processes and maximize innovation efforts.
- Solid knowledge of US food regulations with focus on infant, children, and adult categories in order to provide regulatory guidance and expertise throughout the whole product lifecycle – from early ideation phases to post-launch.
- Serves as Regulatory point-of-contact on project teams to assure MJN products and labeling are in compliance with US regulations and relevant MJN policies and guidelines
- Provide regulatory guidance on Product Development Formulation Specification (PDFS) development and changes; provide regulatory guidance on formulation Out of Specification (OOS) requests. Oversees technical label copy (TLC) preparation for MJN products; reviews and approves artwork and proofs for accuracy; and reviews and approves promotional materials in accordance with the LEX (labeling excellence) process and procedures.
- Stays abreast of, interprets, and communicates existing and/or proposed government regulations, registration requirements, and labeling changes to Operations, Business, and R&D functions and applies these changes as necessary to facilitate MJN's business plans and long-term goals.
- Understands and communicates US FDA regulations and procedures for MJN products, especially Infant Formula, and how regulations may impact work assignments.
- Reviews Regulatory Affairs standard operating procedures and work instructions as needed.
- Coordinates the maintenance of accurate databases for regulatory submissions, references, internal documents, export market registration, and web-based applications and shared drives for document sharing.
- Supports industry association activities related to US-manufactured products.
- Drives regulatory processes to ensure timely FDA filing, registration (including exported products), approval, and/or maintenance of product registration in accordance with US regulatory requirements and business objectives.
The experience we're looking for
- At least 5 years of work experience in Regulatory Affairs / food industry.
- Demonstrated ability in managing intricate regulatory issues and in preparing and maintaining dossiers such as registration submissions for regulated products.
- Demonstrated ability to work with a range of technically and culturally diverse people, collaborate in team projects, and deliver value-added business results that meet high quality requirements within tight deadlines.
- Understands the regulatory and political environment influencing the infant and young children nutrition industry.
- Master’s Degree in scientific disciplines, such as Nutrition, Food Science, Chemistry, Pharmacy or Biochemistry and/or equivalent experience in food regulation-related field preferred.
- Familiarity of the necessary requirements and time constraints for registration, labeling and advertising of MJN products.
The skills for success
What we offer
Salary Range
Pay Transparency
The base salary range for this role will vary based on experience in job and industry, training and education, skills relevant to the position, and other factors permitted by law. In addition to the base salary, the position is eligible for an annual discretionary bonus, which is subject to change each year. Reckitt offers eligible employees competitive benefits including medical, prescription, dental, vision, and life and disability insurance; paid time off for vacation, sick and Company recognized holidays; a 401(k) plan; 16-week paid parental leave or 26 weeks for the birthing parent; adoption and fertility support; tuition reimbursement; discounts; and much more. Our compensation and benefits packages aim to give our talent the reward, protection, and peace of mind they deserve. If reasonable accommodation is needed to complete your application, please contact NAtalentacquisition@reckitt.com. Reckitt is committed to the full inclusion of all qualified individuals.
Equality
Nearest Major Market: Evansville
Job Segment:
Counseling, Nutrition, Pharmacy, Healthcare