Regulatory Affairs Manager

TPI Norway  is seeking a Regulatory Affairs manager to join their API and CMO business based in Kragero Norway.

About TPI Norway
TPI is a rapidly growing global supplier of pain relief, cough and anti-addiction active pharmaceutical ingredients and solid oral dose tablets. We are a fully integrated opiate manufacturer from poppy cultivation to tablet production and pride ourselves on being the lowest cost narcotic raw material (NRM) and API manufacturer with novel water based extraction technology. The company was founded in 2004 and is listed on the Australian stock exchange. We have manufacturing sites in Victoria Australia and Kragero Norway.


RESPONSIBILITY, AUTHORITY AND PURPOSE
 
The Regulatory Affairs Manager will:
 

• Provide the CMC (Chemistry, Manufacturing and Controls) regulatory leadership and strategy required to achieve regulatory approvals. 
• Ensure current knowledge and understanding of existing and emerging API regulatory requirements/ procedures/best practices in all relevant markets to ensure customers obtain and maintain Marketing Authorisations with minimum delay/deficiencies. 
• Interpret and communicate new regulations, guidelines and policies to other staff where applicable. 

• Collaborate closely with R&D/Quality/Production to generate the required data during process and analytical development to satisfy the regulatory authorities in all relevant markets. 

• Collect, collate and evaluate data provided by R&D/Quality/Production. 

• Review data/reports to be incorporated into regulatory documents to assure scientific rationale, accuracy and clarity of presentation; review batch records, specifications and test methods for compliance with current requirements.

• Advise on manufacturing/quality control strategy with regard to regulatory requirements; develop and write clear arguments and explanations to justify that strategy. 
• Collaborate closely with Sales to ensure awareness of customer activities/sales strategy in order to provide efficient and effective technical/regulatory support to customers and align regulatory activities with the company's commercial goals. 
• Prepare and submit regulatory dossiers (DMFs, CEPs) for APIs to customers/regulatory authorities in accordance with regional requirements. 

• Advise on manufacturing/quality control strategy with regard to regulatory requirements; develop and write clear arguments and explanations to justify that strategy. 
• Collaborate closely with Sales to ensure awareness of customer activities/sales strategy in order to provide efficient and effective technical/regulatory support to customers and align regulatory activities with the company's commercial goals. 
• Prepare and submit regulatory dossiers (DMFs, CEPs) for APIs to customers/regulatory authorities in accordance with regional requirements. 

• Prepare and submit technical packages for NRMs and API intermediates to customers in accordance with regional requirements. 
• Provide support for customer services regarding any regulatory matters. 
• Respond to regulatory questions relating to new applications and post-approval changes from customers and regulatory authorities. 
• Ensure continued compliance with all regulatory documents by managing product lifecycle:
  • Work with Quality to assess planned changes and determine requirements for customer and/or regulatory authority approval/notification.
  • Agree implementation plan with Sales/Supply Chain.
  • Liaise with customers prior to change and provide regulatory support during transition.
  • Work with R&D/Quality/Production to generate required supporting data.
  • Prepare and submit updated regulatory documents and technical reports justifying the change to customers and/or regulatory authorities.
  • Work with Sales/Supply Chain during the transition to monitor customer acceptance and implementation. 
  • The regulatory Affairs Manager reports to the Quality Director.
    
    For more information about the position, please contact Annemieke Nesse, Branch Manager Kelly Scientific Resources on +47 92208761.