Senior Regulatory Consultant (remote-based)

Hobson Prior are looking for a Senior Regulatory Consultant to join a fantastic CRO on a permanent basis with the ability to complete tasks from anywhere in Europe apart from France and Germany. Our client is focused on assisting advanced organisations.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will adhere to the deadlines both internally and HA deadlines.
• Guarantee proposals are accomplished and precise and conform with suitable regulatory needs and expectations.
• Plan and organise the evaluation and sanction of proposal-ready reports.
• Contribute to conversations on regulatory methods with a varied shareholder network such as QA, Brand Leads, etc., with assistance from a SME.
• The ideal candidate will cooperate with RA CMC associates and SMEs to comprehend and summarise multifaceted data.
• Any other assigned duties.

Key Skills:

• Diplomacy capabilities with the ability to resolve issues.
• Communication skills both verbally and in writing.
• Ability to handle client relations.
• Capable of conducting face-to-face meetings with clients.

Requirements:

• Experience working in a CRO, Pharma or regulatory establishment.
• Comprehension of change management procedures and regulatory needs.
• Familiarity operating on simple and multifaceted APAC and LATAM proposals would be advantageous.
• Educated to a degree level in a life science, pharmacy, medicine or similar field.
• Acquaintance with CMC proposals of Simple (Type I) and multifaceted variations (Type II) to EU markets in the CP, MRP and NP procedures.
• Past involvement with change control evaluation such as the implementation of pertinent regulatory direction to suggested change.
• Experience in regulatory affairs.
• At least 3 - 5 years of experience with CMC regulatory, preferably with small molecules or biologics.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.