Senior Regulatory Affairs Specialist

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business.  This could include areas such as plasma related (PMF), facility related, or preparation of product specific submission packages to global health authorities to support business needs in a very timely and accurate manner. 

 

Sr Reg Affairs Specialist I

Primary responsibilities for role:

• Act as Regulatory Affairs representative for specified key products/facilities/equipment.                     
• Prepare complex submissions to various governmental agencies and ensure contents are in compliance with domestic and international regulatory requirements.                                                     
• Prepare recurrent and routinely requested data, listing, and notifications for assigned projects for submission to regulatory agencies.                                                    
• Prepare official submissions to regulatory agencies for new or modified products.                   
• Prepare responses to regulatory agency inquiries.                                                            
• Compile regulatory submissions through coordination with other departments and research of internal documentation, complete applications and forms, compose cover letters and summaries, assemble/format submissions in such a manner to facilitate the review process                                                          
• Inform other departments on new regulatory developments.                                                      
• Research regulations and guidelines and interact with domestic and international regulatory counterparts to provide effective regulatory assessment of proposed changes to products/facilities/equipment.                                       
• Perform other duties as required.

 

Additional Responsibilities, Knowledge, Skills and Abilities:

• Global Regulatory CMC Experience is preferred. 
• Ability to work independently and complete tasks timely.
• Superior skills with the use of MS-Word, Adobe Acrobat and Adobe plug-in tools; a high degree of attention to detail and troubleshooting skills; knowledge of global health agency submissions requirements (CTD/eCTD).
• Ability to work as part of the regulatory team to meet group objectives and business needs.
• Ability to clearly communicate verbally and in writing with external contacts that may include industry representatives, regulatory authorities at the federal, state, and local levels.
• Ability to work with other computer / software systems as needed.
• Ability to work under tight timelines to meet deadlines and business objectives.

 

Requirements:

• Bachelor’s degree in relevant discipline, or equivalent work experience / industry regulatory experience.
• Minimum 4 years of related technical and/or regulatory experience in pharmaceutical industry                                                                                                                                                                   
• Experience with the pre-clinical, clinical, chemistry, manufacturing, and controls of biological products and/or e-submissions and regulatory information management experience.
• Knowledge of applicable laws and regulations.
• Proficient with Microsoft Office (particularly Word).
• Ideally should have e-submissions and regulatory information management experience.