Regulatory Affairs Manager

Durham, NC 27722

Post Date: 04/02/2018 Job ID: 110.18LR Industry: Laboratory - Industrial Chemicals

Regulatory Affairs Manager

Reporting directly to the R&D Manager, this position is responsible for evaluating and communicating product compliance for global environmental, health, and safety regulations, including FDA and EU Food Laws.  This position will work with suppliers and manufacturers to create, maintain, and annually update a regulatory database of the raw materials.  Additional responsibilities include:

*Engaging directly with customers to support their regulatory activities and respond to all requests for regulatory information.  Develops content and format for regulatory submissions, such as INDs (Investigational New Drugs), BLAs (Biological License Applications), NDAs (New Drug Applications), and related supplements and amendments

*Establishes and maintains sustainable processes to respond to customer and regulatory agency requests

*Advises corporate personnel regarding the development and implementation of regulatory strategy, potential areas of regulatory strategy, potential areas of regulatory concern, and new government / regulatory developments

*Negotiates directly with regulatory authorities regarding company's filings

*Reviews and approves technical data, and verifies accuracy of data and execution of projects to regulatory authorities

*Develops, implements, and reviews current policies and practices issued by Federal and International regulatory agencies

*Serves as regulatory affairs representative on assigned teams to provide input on phase I, II, and III filing activities and to ensure that report systems are maintained

*Coordinates with other departments and international offices to achieve project goals

*Reviews regulatory publications to keep apprised of new regulatory developments

*Develops standard product regulatory statements to provide efficient indirect support to customers on frequently requested regulatory topics

**If you'd like to hear more about this opportunity and others we are currently working on, please contact Larry Riederer at 815.756.1221 / [Click Here To Join].

JO:  110.18LR


*MS or PhD in Chemistry, Material Science or equivalent field preferred

*Professional regulatory certification preferred

*6-10 years of experience with product environmental, health, and safety compliance regulations that includes FDA (direct and indirect food contact), chemical product Safety Data Sheet management, REACH, TSCA, EPA, etc.

*Prior Product Stewardship or Regulatory Affairs work experience, ideally with chemical or chemical related products

*Excellent organizational and prioritization skills

*Process analysis and improvement mindset

*Strong verbal and written communications with ability to translate complex subject matter for understanding

*Excellent interpersonal skills ability to work effectively at all levels and functions, cross-culturally and with internal and external contacts within the technical, regulatory and sales communities

*Recognized for being highly customer focused reliable, timely, responsive and accurate communications

*Demonstrated ability to manage projects across complex organizations

*Self-starter with ability to think and act independently and to make sound recommendations and decisions

**If you'd like to hear more about this opportunity and others we are currently working on, please contact Larry Riederer at 815.756.1221 / [Click Here To Join].

JO:  110.18LR

Larry Riederer
Market Specialist

I have over 20 years of experience with Chemical Personnel Search (CPS) . All we do is recruit and place people in the chemical industry nationwide. CPS has been recruiting chemists, engineers, sales people and supply chain since 1973. I work with 40 other recruiters. 

I have a wide range of positions and levels.
The following are some of the areas: Polymers, Resins, Coatings, Adhesives, Inks, Composites, Plastics, Lubricants, Personal Care, Skin/Hair Care, Cleaners and Specialty Chemicals.

These can be: Organic/Polymer Synthesis, New Product Development, Analytical/Characterization, Quality Control, Process Development, Materials Science and others. These are from BS to Ph.D. and from Entry Level to Vice-President. 

Specialties: We specialize in placing Chemists, Scientists and Managers in the industrial chemical industry


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