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Job Details

Regulatory Affairs Manager - Scotland - Contract

Company: Umbilical Life
Location:
Reference: MATTRAMGERSCOT
Closing Date: 25 Nov 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Matt at Umbilical Life is recruiting an experienced Regulatory Affairs Manager, on a Contract basis for a leading Pharma in Scotland.

Requirements:

Responsibilities:

Draft, compile and assemble high quality and complete Drug Master Files (DMF) applications and primarily the Chemistry, Manufacturing and  Controls (CMC) sections of Investigational New Drug (IND), New Drug Applications (NDAs) and Abbreviated New Drug (ANDA) applications  in Electronic Common Technical Documents (eCTD) format for transmission to MHRA.

Evaluate the regulatory impact of proposed product and/or process changes

Interface with project team members to obtain documentation, establish timelines and ensure complete and accurate submissions are made according to plan

Critically review documentation intended for submission to the MHRA for internal consistency and against any relevant guidelines

Review change control documents and contribute to decisions regarding the appropriate regulatory filing mechanism and documentation to support same

Review current departmental Standard Operational Procedures (SOPs) and suggest and draft new SOPs

Provide assistance in review of draft labeling

Participate in special projects as assigned.

Qualifications:

Minimum Bachelors degree in a scientific or life sciences discipline required.

Minimum of three years pharmaceutical industry experience required. 

Microsoft Office (Word and Excel) proficiency required.

Hands-on CMC experience and a strong understanding of CMC requirements preferred.

Excellent verbal and written communication skills required. 

Must be able to work within a team as well as independently and be able to multi-task required. 

 

For a confidential discussion please contact Matt at Umbilical on +44 (0) 116 461 0081 or email matt@umbilical-life.com

Apply for this job: Regulatory Affairs Manager - Scotland - Contract

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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