Regulatory Affairs Manager

03 Nov, 2021

Jobs

Regulatory Affairs Manager

FrieslandCampina
Paramus, NJ

The Regulatory Affairs manager performs a key role in maintaining the compliance to internal and external standards and policies for North America. This is achieved by being the expert on (special) food legislation and having an extended network to source information for the region.

 

A key role for the manager is the correct interpretation of the contents of legislation and the capability to translate this knowledge into activities. The RA manager is fully up to date with the developments in legislation and anticipates on new legislation by supporting projects and activities to prevent non-compliances. In addition, the regional teams are updated regularly on new legal developments as well as new developments in standards and policies. The RA manager has an important role in performing regulatory risk assessments for projects and drives the process of registrations of products and locations for export purposes. The RA manager works closely with the regional Customer QA mgr in their contacts and support to customers.

The RA manager is part of the Ingredients RA community and can represent RFC’s positions internally as well as externally in relevant expert groups and organizations. Moreover, the jobholder is actively involved in the design, review and optimization of standards, policies and guidelines.

What we ask

Key knowledge and experience:

  • Bachelors of Science in a Food Science or related field; Masters in Food Science preferred
  • Expertise in Federal & State Regulatory legistlation governing speciality ingredients manufactured in Dietary Supplements, Adult/Performance nutirtion food& beverages, infant nutrition and pharamaceutical products
  • Knowledge of Food Legislation, experience with legal databases (EurLex etc.)
  • Possess excellent verbal and written English communication skills
  • Must demonstrate learning agility, professional growth, knowledge of supply chain, regulatory affairs, food safety
  • Possess sound time management and continuous improvement mindset
  • Demonstrated ability to lead a project, set and meet smart KPI’s, being proactive and acting independently to network his/her way within the organization.
  • Ability to work with ambiguity and under pressure while managing competing deadlines
  • Advanced working Knowledge of MS Word, PPT, Outlook along with sound navigation skills to expediently learn new/use technology systems.
  • Ability to operate effectively in a network/matrix reporting lines
  • Possess influencing skills and ability to develop strong rapport and relationships with internal and external customers to ensure worry free service is delivered
  • Ability to work effectively and efficiently (avoids batting emails around)
  • Must be self-driven and possess the ability to work independently and collaboratively with a commercial team
  • Possess keen attention to details and level of accuracy
  • Internationally oriented and culturaly sensitive
  • Knowledge of infant formula preferred

Competencies:

•    Proactive
•    Keen attention to details and analytical
•    Superior Problem solving skills
•    Consultancy and Team Player skills
•    Convincing/inspiring, thinks out of the box
•    Results oriented
•    Organizational awareness & can see the bigger picture

What we offer

At FrieslandCampina Ingredients we take good and transform it into great!  

FrieslandCampina Ingredients is a world-class, global leader in dairy value-added, healthy and functional ingredients and solutions. The markets and our customers are highly dynamic and to make a difference we are commercially obsessed in understanding the needs of our customers and the consumers.  We are purpose driven and every year we raise the bar in bringing high quality, value add ingredients and solutions to our customers. Our ambition is to nourish the world, be specialists in proteins and gut health, not just milk proteins.

 

FCI helps customers win in the market, especially where nutrition matters most such as the infant & toddler nutrition, adult performance, lifestyle, healthy aging along with medical and cell nutrition industries with natural, value-added ingredients.

Vacancy description

The Business Group FCI is focusing on producing and selling premium quality ingredients for infant, medical and performance nutrition for its global customer base. Quality Assurance, Food safety & Regulatory Affairs discipline (QA) is the policy-making body of FC Ingredients in the field of Quality Assurance, Food Safety, Food Security and Regulatory Affairs.

The mission of the group is to be the trusted conscience that leads & supports in quality, food safety & compliance. The director Quality Assurance at FCI is reporting into the President FCI to secure independency.
Regulatory affairs is represented in the global team and in the regions. The RA manager works closely together with multiple teams to continuously assure legal compliance of our business.

 

Provide Technical Intelligence and ensure compliance of our products to legislation, policies, standards

  • Design, implement and improve processes and procedures to ensure compliance of the BGI business processes.
  • Identify and report non-compliant situations and facilitate resolving the situations.
  • Monitor regulatory intelligence impacting product compliance
  • Stay apprised of new developments is legislation, policy and standard development and translate these developments for the business group.
  • Provide the central team with information and guidance to translate RA-requirements into FCI
  • Perform impact and risk assessments of non-compliances.

Inform and Advice the internal organization (Innovations, Cat. Teams, MTs, etc.)

  • Answer questions relating to RA from  the various stakeholders in an effective way.
  • Supports the BGI Change control board upon request
  • Give regular updates to relevant organizations (e.g. OPCO MT’s, SC MT) about regulatory affairs
  • Develop positions and prepare statements concerning regulatory affairs subjects
  • Participate in the RA core team where applicable.

Business Partnering / Customer Facing

  • Advise customers on local soft/hard claims
  • Advise regional Customer Connectivity on potential soft/hard claims

Coordinate network of local consultants

  • Managing regional RA budget
  • Focusing on FCI’s big rock innovations for the region, in line with long term plan

Perform regulatory risk assessments (RRA) / impact analysis

  • Execute RA risk assessment and impact analysis in relevant projects (focus region).
  • Participate in clearance meetings and representing RA (focus region)

Monitor Regulatory Affairs: developments, issues, upcoming legislation/ regulations / Codes/ acquisition

  • Keep up to date with developments in the relevant industries, analyse and summarize developments and formulate actions.
  • Inform the stakeholders about RA developments

Organize lobby & advocate the RFC position(s) (align with Public Affairs where applicable)

  • In close collaboration with Corporate Affairs, organize lobby and influencing activities to protect the RFC business.
  • Influence and connect with local authorities regarding RA-matters
  • Represent the interest of RFC in external expert groups and organizations
  • Develop and collect information to back the RFC positions, collaborate with external organizations which represent RFC’s interest

Drive and support the development, maintenance and  implementation of RA Policies, Standards, Guidelines, Processes and procedures (‘Top down & Bottom up’ approach)

  • Develop initiatives to create new policies, standards, guidelines etc. where applicable.
  • Identify needs for new policies, standards etc. within the business and develop these documents.
  • Participate in policy implementation by organizing/giving  training, discussions, workshops etc.

Be the internal and external RA representative/ authority

  • Participate in internal project teams, working groups etc. to represent BGI
  • Participate in relevant external organizations to represent BGI as well as FrieslandCampina.

Align within the RFC organization / internal stakeholders

  • Develop and maintain an internal stakeholder network

At FrieslandCampina Ingredients we take good and transform it into great!  We believe that we need to embrace the challenges we are faced with so we work tirelessly to increase nutritional benefits, new sensory experiences, and innovative application methods to bring more goodness to our products and the customers we serve.  The markets and our customers are highly dynamic and to make a difference we are commercially obsessed with understanding the needs of our customers and the consumers. We are purpose-driven and every year we raise the bar in bringing high-quality, value add ingredients and solutions to our customers. Our ambition is to nourish the world, be specialists in proteins and gut health, not just milk proteins.

 

We are an affirmative action and equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.  FrieslandCampina Ingredients North America, Inc. expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, veteran status, or any other protected classification under the law. Improper interference with the ability of FCINA’s employees to perform their job duties may result in discipline up to and including discharge.

Apply now

Job posted: 2021-11-03