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16 Jan, 2020

Global Regulatory Strategy Lead - Pharma Solutions

  • Big House Group Ltd.
  • Paris, France
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Töö kirjeldus - job description.

DuPont Nutrition & Bioscience is a USD 6.2 billion global business and one of the world’s largest producers of specialty ingredients, developing and manufacturing solutions for the global food & beverage, health & bioscience and pharma markets. With more than 10,000 employees, 70+ manufacturing sites and 25+ R&D centers across the world, N&B is on a mission to provide essential innovations from highly engineered products and naturally sourced ingredients to shape industries and everyday life.


DuPont Pharmaceutical Solutions represent one of the industry’s broadest and most flexible portfolio of oral solid dosage advanced pharmaceutical ingredients and excipients. Our solutions for tablets, capsules, multiparticulates and suspensions help modern medicine meet consumer demand for better health with a full range of immediate, delayed, and sustained release options; taste masking; enhanced bioavailability for novel advanced pharmaceutical ingredients; and naturally derived vegetarian capsules.

 

In the Global Regulatory Affairs & Product Stewardship (RAPS) team we have an opening for a Global Regulatory Strategy Lead (GRSL) to drive regulatory activities for our $800MM Pharma Solutions Business.

The global Regulatory Affairs & Product Stewardship organization employs more than 115 highly specialized and committed colleagues worldwide and has a footprint in more than 20 countries. Our work environment is truly international, and we offer a dynamic working culture focused on partnership, cross-organizational collaboration, and individual development opportunities.


The role reports to the Head of RAPS Strategy and can be located in US (Wilmington, DE – Midland, MI), NL (Leiden), DK (Copenhagen) or FR (Paris).

RESPONSIBILITIES / ESSENTIAL FUNCTIONS:

The Global Regulatory Strategy Lead is accountable for delivering innovative regulatory strategies as well as tactical expertise for development and maintenance of our Pharma Solutions products. This includes leadership for the RAPS matrix team focusing on the pharma solution products and involvement in product registrations and direct agency interaction worldwide (e.g. with major global agencies like FDA, EMA, NMPA, PMDA, etc.). The position will also function as a strategic partner for both Business Leads in the commercial organization and Technology Leads in R&D..

Specific Responsibilities Include:
  • Interfaces with business R&D and Commercial/Marketing functions to define optimal regulatory pathways aligned with business plans, development opportunities and R&D objectives.
  • Leading optimal evidence generation and differentiation based on early integration of evolving scientific/regulatory trends
  • Develop, submit and support DMF, CEP, GRAS, NDI or national legislations dossiers for approval of excipients and food additives, including addressing evaluation questions from various member states.
  • Coordination of scientific work to support risk assessment (testing program)
  • Provide Global regulatory input during cross functional business projects meetings
  • Support customers for regulatory matters and answer queries
  • Provide issue management support for products and activities across key external stakeholder groups
  • Identify advocacy needs for the product line and work with colleagues in Regulatory Sciences and advocacy team to pro-actively track and assess impact of WHO, FDA, EFSA, CODEX, ICH, EMA, CFDA, India, etc. guidance documents with reference to API’s, excipients and direct food and feed additives, and impurities there-in
  • Active interface with competent authorities to understand regulatory issues of direct impact to the use of DuPont N&B products in finished drug products and food. 
EXTERNAL FOCUS:
  • Expected to spend up to 10-15% of time external to the company supporting business customer interactions, trade associations or interacting with government officials.




 

Job Qualifications

 

 PREFERRED EXPERIENCE & QUALIFICATIONS:

  • PhD or MSc degree in Pharmaceutical Science, Biology, Toxicology, Environmental Science or Chemistry.
  • + 5 years work experience from Regulatory Affairs (CMC) in the Pharmaceutical Industry
  • Related work experience in pharmaceutical and/or food additive registrations
  • Experience or practical knowledge from the food industry would be a plus
  • Demonstrate analytical, conceptual and strategic thinking as well as excellent communication skills
  • Fluency in the English language
  • Strong interpersonal skills
  • Very good organization, and project management competences

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