Description
Principle / Project Manager x 3 positions - Up to £60,000 + 15% bonus and extensive benefits packageA growing international Pharmaceutical Company is currently working exclusively with Real Pharma in the acquisition of a new Regulatory Branded Pharmaceutical team in Oncology and Pain. This multimillion pound organization has had exponential growth over the last 75 years and as a result is looking to fill these integral roles which will have massive impact to the success of the business.
This organization has Branded product in several therapy areas including Oncology, Urology, Mental Health, Pain, Parkinson's, Nervous systems, Respiratory and Asthma. This company is a top 10 Pharma and is globally recognized.
Reporting to the Head of Regulatory Oncology and Pain you will work as a key Regulatory expert in the team. There are 5 positions ranging from Senior Regulatory Officer up to Regulatory Principles / Experts.
As an expert in Regulatory your duties will include:
- Managing both centralised and decentralised filings of branded medicinal products inEurope.
- Ensure that regulatory obligations for marketing authorisations are met and provide a point of contact for EMA or national competent authorities
- Coordinate all regulatory aspects in connection with clinical trial applications inEurope
- Collaborate with internal/external teams, providing European regulatory advice to Global Regulatory Affairs, General Management, medical and marketing departments and project teams on appropriate strategies for in-licensing and other potential opportunities
- Participate in the development of RA strategies for new product submissions
- Provide supervision and support to other regulatory professionals and administrative support staff.
Actively support project teams providing European specialist regulatory advice from early stages of pre-clinical development of new chemical entities, ensuring "label-driven" product development
If you are interested in this position you must have:
- Previous experience in Regulatory Affairs in Branded Pharma
- EU Regulatory Experience
- MRP Variation / Renewal experience
- PSUR exposure
- MAA (Would be a plus)
- National product experience
- Excellent Communication skills
There is a potential career path to overall company management available for the right individuals, which is incredibly rare in the current market.
They are looking to offer a salary of up to £60,000 as a basic, plus 15% bonus and an extensive benefits package along with flexible working hours.
If you are interested in the position, please send an updated CV to Natalie Hopkins. For further details on location and company please call .
To find out more about Real please visit www.realstaffing.com