Regulatory Affairs Market Authorisation Project Manager Essential: Regulatory Affairs. Market Authorisation. Regulatory strategies and maintenance. Product legislation. Immediately available.
Regulatory Affairs is a key component within the pharmaceutical product life cycle. Within that market authorisation plays a key role in ensuring all relevant licences are in place to make the product available across the market in various regions. To support this function, my client, a world renowned pharmaceutical company is looking hire regulatory affairs personnel to join their evolving regulatory team.
Regulatory Affairs Market Authorisation Project Key Responsibilities:
- Responsible for tasks associated with market authorisation for Ireland and UK
- Primary contact with regulatory authorities regarding product licences and maintenance activities
- Notify relevant bodies of all safety and quality issues, ensuring they are being dealt with and expedited where necessary
- Ensure all product information contained within SPCs and PILs are compliant for market authorisation
- Ensure all SPCs and PILs are accessible to healthcare professionals via compendia
- Respond to all regulatory related quires ensuring the information is aligned to agreed strategy
- Complete and review Market Authorisation Holder (MAH) periodically
- Coordinate meetings with regulatory agencies playing a key role in the overall outcome
- Effective planning of regulatory activities with clearly outlined timeline
- Take a proactive lead displaying leadership and providing suitable solutions to all queries
- Life sciences graduate with extensive experience within regulatory affairs for the pharmaceutical industry
- In-depth understanding of all aspects of regulatory affairs for the UK and Ireland
- Sound knowledge of drug development and overall product life cycle
- Proven project management skills demonstrating leadership and ownership of outcome
- Knowledge and experience troubleshooting commercial and medical issues
- Awareness of competitor product and activities
- Good interpersonal and influencing skills
- In depth understanding of regulatory governance
Please contact Syeda Afsana Islam on 0161 942 4060 for more information on rates and applying.
Regulatory Affairs Market Authorisation Project Manager – Hertfordshire – Contract – 12 Months