Pharmalink Consulting - Worldwide Regulatory Affairs

Regulatory Associates/Managers/Senior Managers

Job Description
We are one of the world’s leading Pharmaceutical Regulatory Affairs Consultancy companies, with offices in the USA, UK and India.

Over the past year, our growth in the USA has been phenomenal and we have experienced unprecedented success through building strong relationships with our clients, understanding their business and providing quality Regulatory Consultants with the right experience to meet their needs.

Due to our success, we are seeking enthusiastic Regulatory Affairs Professionals to join our growing, fast-paced, dynamic consultancy team.

• Candidates with varying years of experience (Regulatory Associate to Senior Manager) are required to primarily focus on two large projects we are currently working on from our Pharmalink office locations.
• General regulatory knowledge required with a focus on CMC and/or International experience a plus.
• One role requires previous experience with generic products.

Overall accountabilities
• Maintain, prepare and compile a variety of US and International regulatory applications for both pre-approval and post-approval products with or without supervision dependent on experience.
• Preparation of the content and structure of regulatory filings.
• Assist or prepare responses to Health Authority queries relating to an application or submission.
• Review and compilation of CTD Modules.
• Collect submission data and regulatory intelligence information.
• Contribute to the regulatory filing strategy output for use by a project team.
• Ensure that project work proceeds according to agreed deadlines and maintaining status records.
• Understand, evaluate and explain complex information.
• Liaises with relevant personnel within the working environment to obtain an understanding of client requirements and future resourcing needs.
• Dependent on experience, manage larger parts of a regulatory project.
• Communicates effectively and develops good working relationships with all personnel.

Skills/Experience Required
• Ideally BSc Degree(or higher) in a scientific field
• Ability to assimilate new skills quickly and effectively
• Good written and verbal communication skills in English
• Ability to demonstrate good working knowledge of IT systems
• Ability to work effectively within a cross cultural team
• Attention to detail, right- first time mentality
• Flexible, resourceful and adaptable
• Ability to travel