Regulatory Affairs Senior Officer

A visionary pharmaceutical company is advertising a vacancy for a Regulatory Affairs Senior Officer to their office in Barcelona. The organisation researches and develops allergy treatments and pride themselves on their pipeline of products in clinical development. This is an exciting opportunity to work with a leading company and provide real expertise to this specialist company's regulatory team.

Job Responsibilities:

• Ensuring regulatory systems, such as Regulatory Database /trackers are implemented and kept up to date.
• Working with internal & external customers to provide data and accurate regulatory input.
• Preparing and reviewing labelling/packaging texts.
• Carrying out promotional reviews.
• Actively participating in regulatory projects or acting as a regulatory representative on ATL projects, meeting timelines.
• Understanding relevant legislative and regulatory guidance applicable to activities of AT.
• Actively becoming involved in concepts of RA Strategy team.
• Attending industry and RA meetings.
• Communicating with regulatory agencies and document communication.
• Reviewing and signing off change control impact assessments.
• Preparing & reviewing assigned SOPs.
• Training and mentoring regulatory team members.
• Mentoring and providing supervisory support to RA Offices Level 3
• Providing local RA support to local departments (sales, marketing, customer services, logistics, QA, LSO, etc.).
• Preparing and reviewing labelling/packaging texts.
• Reviewing artwork and published SPCs (Spain).
• Reviewing and approving Promotional Material.
• Facilitating local contact/communication with local regulatory bodies.
• Preparing and updating local SOPs.
• Overseeing new product licence application dossiers in preparation for introduction of new legislation in various countries.
• Reviewing updates to the local regulatory environment and suggest impact at ATL Corporate Regulatory.
• Preparing & reviewing new product dossiers, annual updates, and high-quality timely submissions/responses and following up of actions arising from Regulatory Authority commitments.
• Preparing and reviewing CTA/IND submission and maintaining documentation for Regulatory Authority commitments, quality, and safety reviews.

Skills and Requirements:

• Relevant life sciences degree.
• Minimum of 4 years in the regulatory pharmaceutical field.
• Demonstrated ability to write good quality documents.
• Project management.
• Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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