CMC Regulatory Specialist (Madrid cinturón)

We are searching for a well-known pharmaceutical group located in Madrid a CMC Senior RAO Specialist. Our client offers a headquartered position in its international RAO team located in Spain which is registering dossiers (own products and licensed ones) around the world. Direct hire and permanent contract is offered with interesting opportunities of careers development. 

Job Description 

The CMC Regulatory Affairs Specialist is responsible for the development of regulatory affairs strategies specific to quality dossiers, and submission and negotiation of regulatory submissions from clinical trial to the post-market stage. The incumbent will ensure quality compliance of post-approval activities. In this role, the incumbent will focus on preparing and following up on Chemistry, Manufacturing, and Controls files, as well as work closely with multiple scientific, technical, quality, and commercial areas within the company. The incumbent will elaborate the eCTD dossier from zero M1 to M5 for generic products. 

This position also works closely with the QA and also directly interacts with manufacturing sites as needed. Externally this position interacts with Health Authorities, industry organizations, consultants, vendors, and health care professionals. 

Responsibilities 

GENERAL RESPONSIBILITIES:

Regulatory Affairs

 Providing CMC oversight and regulatory interface with Health Authorities 

 Review (including conducting regulatory impact assessments), coordinate and prepare CMC documentation for Clinical trial Applications (CTA), CTD modules of submissions, registration and lifecycle management variations.

 Obtaining and maintaining regulatory approvals

 Transfer of registered data to registration summaries and updating of electronic regulatory information system

 Management of regulatory affairs electronic storage of CMC data

 Participate as required in project Launch Meetings, Review Meetings and Project Team meetings 

Profile 

SKILLS AND QUALIFICATIONS:

 Bachelor of Science

 3-4 years of experience in regulatory affairs in the pharmaceutical industry.

 Significant experience with CMC modules I, II, III and international regulations and file transfers

 Detail oriented person, with strong capability to multi-task

 Understanding of pharmaceutical manufacturing a strong asset

 Ability to work well both independently and in a team environment

• Solid decision making skills with strategic mindset. • Excellent communications skills (verbal, written, listening, conveying messages) • Solid computer skills • Experience in Quality Assurance/Quality Control • Experience with eCTD and non-CMC regulatory affairs is an asset

Contact Information 

Candidates must send CV and application letter in English to recruitspain@valesta.com

Important 

Prior CMC / Module 3 experience is MANDATORY. 

Application form : CMC Regulatory Specialist (Madrid cinturón)

Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.

I want to stay informed.

I would like to receive Valesta news, valuable insights into industry trends, career opportunities, trainings, and other helpful tips to find assignments that match my skills and interests. Click here to stay connected with Valesta.

Valesta is an expert in life science recruiting and project staffing.  The information you are submitting is important for us to respond to your assignment and contract needs. In compliance with the General Data Protection Regulation (EU) 2016/679) (“GDPR”), Valesta will process your personal data in accordance with our Privacy Policy. Valesta will safeguard your personal information and not disclose to any person unlawfully. As a staffing company, Valesta receives and processes your personal data for the following purpose: to take appropriate steps to find you an assignment with one of our clients and/or to finalise a contract with you.

Please note that Valesta does not wish to receive any data from you if you are under the age of eighteen (18) or data that is classified as Sensitive Data under the GDPR; this includes personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic/biometric/health-related data or data concerning a person's sex life/sexual orientation.

Please read our disclaimer.