Regulatory Affairs Expert PHS America

15 Nov, 2021

Jobs

Regulatory Affairs Expert PHS America

Klöckner Pentaplast
Gordonsville, VA

kp is a leading global manufacturer of rigid and flexible packaging and special films. We have a clear goal: the sustainable protection of important everyday products. You will find our customers in markets from pharmaceuticals to food and consumer goods. With our film products, we make sure the products last longer and maintain their important properties. With this we significantly contribute to safety, health and consumer satisfaction. We are as dynamic and fast paced as the markets of our customers. Always in motion! Founded in 1965, we now have 31 factories in 18 countries and employ more than 5,900 people worldwide.

Purpose of the job:                     

Responsible to ensure product compliance to all relevant regulations.

Key player to act as internal consultant in regards of product compliance as well as influencer of relevant regulatory environment

 

 

Key tasks and responsibilities:

  • Manage product compliance in global regulatory landscape
  • Identify key stakeholders to monitor the regulatory environment and proactively interact with authorities and customers
  • Act as internal consultant for product and business development on product compliance matters
  • Establish product compliance matrix and conduct training to commercial team (Business development, Sales, Marketing)

 

 

Strategic impact:

  • Guaranteed product compliance and consulting of regulatory matters (internal & external)
  • Awareness of applicable regulations and standard and their upcoming changes
  • Influence revisions of regulations and standards
  • Communicate selling proposition of products and kp in general as partner in regulatory affairs

 

Functional knowledge and technical skills within own and other areas:

  • In-depth knowledge of Quality Standards used in the Pharma industry
    • ISO 9001, ISO 15378, ISO 13485, cGMP
  • Deep knowledge of the Pharma industry, how it works, the regulatory framework & requirements, in all countries in which kp sell Pharma film (e.g. CFDA, REACH, CFR21, Pharmacopoeia)
  • Knowledge of MOC / CC requirements for new equipment/upgrades and understanding of qualification requirements (DQ, IQ, OQ, PQ), etc.
  • Knowledge of product structures and functionality of raw material groups

 

Educational requirements/qualifications and experience:

  • At least four years’ experience and/or training in regulatory affairs within the Pharmaceutical industry
  • Extensive experience in the Pharma industry, with direct experience of operating in many countries globally and their pharma environments
  • Extensively familiar with audits – supplier audits and regulatory compliance
  • Experience in tariff laws for our products and raw materials
  • Continuous Improvement experience in a pharma process environment

 

 

 

 

Key competencies:

 

  • Verifies compliance with all applicable standards (e.g. ISO 9001, 15378, 13485 cGMP etc.) and assure re-certification of given standards for all kp products and sites producing PMD products
  • Manage product compliance and upcoming market challenges in regards of regulatory requirements (e.g. FDA, CFDA, European Pharmacopoeia, REACH, 10/2011)
  • Establish product compliance matrix for applicable legislation for all PMD sites (US, EU – food contact, pharmacopoeia, DMF, CFDA…), maintenance matrix within SAP regulatory tools
  • Support global and local change control processes to ensure sustainable product and service quality and proper change management and communication to customers.
  • Management of Change process for PMD sites from regulatory point of view (documentation, training, adjustments & migrations tests…)
  • Work cross-functionally with Marketing and Business development to identify and manage market requirements in regards to regulatory and product compliance
  • Support market communication with proactive dossiers on upcoming changes in regulatory environment
  • Drive educational communication for customers on product properties and usual quality related questions in cooperation with the technical application team
  • Represents kp and develops good relations with key customers and quality related regulatory authorities
  • Handling of customer request concerning product compliance
  • Legislation submission and annual updates of all kp Drug Master Files, China (CFDA) – preparing of dossiers for PMD products & sites
  • Support in ISO certification- and customer audits at production sites
  • Establish training for procurement team on regulatory requirements for sourced raw materials
  • Establish training and information material for commercial team on product compliance and customer benefits

Have we piqued your interest? Great. We look forward to receiving your application including your salary expectations and your earliest start date.

Klöckner Pentaplast is an equal opportunity employer, which makes employment decisions without regard to race, color, gender, religion, national origin, age, veteran status, handicap, disability, sexual preference or marital status.

Job posted: 2021-11-15