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Job ID:  41382
Date:  Jan 11, 2021
Job function:  Quality, SHE & Security
Experience level:  Experienced Hire
Business:  DSM Nutritional Products

Regulatory Affairs Manager-Cromwell, CT

DSM – Bright Science. Brighter Living.™

Royal DSM is a global, purpose-led, science-based company active in Nutrition, Health and Sustainable Living. DSM’s purpose is to create brighter lives for all. DSM addresses with its products and solutions some of the world’s biggest challenges while simultaneously creating economic, environmental and societal value for all its stakeholders – customers, employees, shareholders, and society at large. DSM delivers innovative solutions for human nutrition, animal nutrition, personal care and aroma, medical devices, green products and applications, and new mobility and connectivity. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 23,000 employees. The company was founded in 1902 and is listed on Euronext Amsterdam. 

More information can be found at www.dsm.com.

 

The Challenge

Contribute to all i-Health, Inc. regulatoy affairs activities for investigational and marketed products. Partners with quality, operations, marketing, research and development, scientific affairs, legal, suppliers, distributors and consultants, including headquarters to ensure compliance with global and domestic regulations in the development, registration and marketing of consumer products.  Provide research and regulatory framework for expansion of products globally.

 

The Position

  • Strong understanding of regulations affecting i-Health business globally (cGMP’s, labeling, product registrations/notifications, dietary supplements, medical devices, OTC medicines).  Regulatory Affairs defines the internal requirements for new CPG products to ensure efficient regional and global market clearances.
  • Provide regulatory guidance for existing products, new formula/product development, line extensions, product changes and/or new application submissions.
  • Critical responsibility to assure the safety and safe use of consumer products (ingestible, devices, cosmetics, etc.).
  • Regulatory Affairs is responsible for interfacing with external authorities, business partners, and others necessary to complete successful product registration/notifications in desired markets. 
  • Regulatory Affairs will support i-Health, Inc. in regulatory agency inspections or inquiries. 
  • Internally engage with marketing, quality, scientific affairs, research and development  to provide high standard consultant in the areas of expertise  of value to business process.
  • Essential to stay current with the changing global, regulatory environment.  Research industry changes and attend education seminars to ensure i-Health, Inc. regulatory practices adhere to current standards.  Enhance leadership skills for global regulatory management.
  • Provide regulatory insight to the organization for global product development, marketing and expansion efforts. Develop US product labeling, including supplement and drug facts and other markets as required.
  • Review all product labeling for new products along with artwork changes to ensure compliance with US regulations, i-Health/DSM requirements and global compliance.  Ensure appropriate context of claims based on i-Health/DSM approved claims, local territory requirements.  Provide risk assessments when appropriate or requested by key stakeholders.
  • Manage and/or prepare regulatory submissions to appropriate authorities.
  • Review marketing materials for global regulatory compliance.
  • Review and approval internal documentation on behalf of regulatory.
  • Perform regulatory review and approval of complaints and adverse event reports pursuant to internal procedures.
  • Stay abreast of and provide input on changing, global, regulatory environments.
  • Manage regulatory issues and/or crisis situations in timely and appropriate manners.

 

The Ideal

  • Bachelor’s degree in related field (science, toxicology, nutrition or law)
  • 7 to 10 years’ experience in related field (technical, science, nutrition, medical, health) with an emphasis on global product development, research and post launch marketing and regulatory activities.
  • Excellent working knowledge of global regulations specific to CPG for the categories i- Maintain strict ethical, legal adherence and confidentiality at all times.
  • Ability to work across i-Health based functions as well as throughout DSM to meet regulatory requirements.  Demonstrated communication skills to interface with external agencies and business partners.  Ability to assess risk and provide appropriate guidance to the organization.
  • Must be able to travel globally when determined necessary.
  • PC experience
  • Microsoft Office experience
  • Regulatory/Governmental agency internet based programs
  • Health products are marketed.

 

The Reward

Working for DSM means the opportunity to really contribute to improve people’s lives and solving the challenges of today’s world. Challenging jobs, career opportunities and an inspiring environment allow you to enhance your personal development. DSM recognizes that the on-going success of the company depends on the continued development and engagement of our employees and pursues a fair and competitive remuneration policy, recognizing individual and team competencies and performance.

 

Procedure & Contact

Interested in this position? Please apply online via the career portal (https://jobs.dsm.com/)

 

Pre-employment screening procedures are part of the DSM Recruitment & Selection Process. You will be contacted when further information is required.

 

Royal DSM is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, or any other characteristic protected by law.

Royal DSM and its associated companies deliver annual net sales of about €10 billion with approximately 23,000 employees. The company is listed on Euronext. For more information about DSM see http://www.dsm.com or connect on 

DSM in 3 minutes

Do you know that DSM has the broadest portfolio of nutritional ingredients - that millions of people already have our biomaterials in their body - and that our innovations make materials lighter, healthier, safer, stronger, more durable and have a lower environmental footprint? This short 3 minute video shares our portfolio in Nutrition, Health and Sustainable Living