Regulatory Affairs - Senior Manager or Associate Director

RBW are partnered with a pharma company in the UK who are looking for an experienced Regulatory professional to support the Head of Regulatory.

This business have received a lot of interest in a highly competitive space in the market and are proud to be moving towards commercialization.

At a critical stage with successful Phase 3 trial results in hand (plus a pipeline of early-stage compounds), this person will provide senior-level expertise, helping to define and implement the regulatory strategy for the EU and USA.

This which will mean maintaining relationships with competent authorities, advocating the company’s position, and supporting all internal regulatory responsibilities.

Key Functions:

• Ensure all regulatory activities are aligned with the regulatory strategy
• Coordinate the writing and review of submissions to competent authorities, directing submissions through the approval process- aligned with achieving earliest possible approvals
• Monitor and assess national and international regulations and their impact in the company
• Assist in designing, contracting and management of clinical trials from a regulatory perspective
• Liase with competent authorities, and coordinate and contribute to all authority meetings
• Direct relevant internal and external resources, and assess satisfactory delivery of sub-contracted services
• Management of designated contracts in accordance with QMS requirements.
• Comply with the requirements of a Trial Master File, including the Sponsor Oversight File, per the study-specific TMF plan
• Conducts all job-related activities according to the QMS and relevant regulatory and guideline requirements

Education and Experience:

• Appropriate undergraduate degree. Postgraduate qualification also advantageous.
• Minimum 6 years’ experience in regulatory affairs within a multi-discipline Pharma or Biotech drug development environment
• Has supported regulatory approval process of therapeutic drugs in either Europe or the US.
• Established relationships with FDA, EMA and/or MHRA.
• Senior management experience in a small or medium company environment
• CNS therapeutic area experience is beneficial, but by no means essential

Skill and Knowledge:

• Detailed knowledge of the regulations and standards applicable to therapeutic drug approval in the US and/or Europe
• Understands the full value cycle of the pharmaceutical industry, including all stages of drug development
• Understanding of the EU Clinical Trial Directive and ICH requirements governing the international pharmaceutical industry
• Fundamental understanding of scientific research methods and thought processes
• Excellent analytical and communication skills
• Proven organisational and people management capabilities

Important Information:

This is a small and incredibly friendly company, with a supportive culture and a team driven by the desire to create drugs that change the outlook for patients and families affected by neurodegenerative disease.

The role will be majority work from home, but candidates must have the ability to travel monthly to the office in Scotland, as well as internationally in the EU and US as required (expenses paid by the company). Relocation support can be provided for candidates considering a move to Scotland.

Salary is negotiable based on experience.

Please apply today and you will receive a call to discuss in more depth prior to application to the client. If you would like to find out more, please contact katie.dunbar@rbwconsulting.com or 01273 952176.

RBW are partnered with a pharma company in the UK who are looking for an experienced Regulatory professional to support the Head of Regulatory.

This business have received a lot of interest in a highly competitive space in the market and are proud to be moving towards commercialization.

At a critical stage with successful Phase 3 trial results in hand (plus a pipeline of early-stage compounds), this person will provide senior-level expertise, helping to define and implement the regulatory strategy for the EU and USA.

This which will mean maintaining relationships with competent authorities, advocating the company’s position, and supporting all internal regulatory responsibilities.

Key Functions:

• Ensure all regulatory activities are aligned with the regulatory strategy
• Coordinate the writing and review of submissions to competent authorities, directing submissions through the approval process- aligned with achieving earliest possible approvals
• Monitor and assess national and international regulations and their impact in the company
• Assist in designing, contracting and management of clinical trials from a regulatory perspective
• Liase with competent authorities, and coordinate and contribute to all authority meetings
• Direct relevant internal and external resources, and assess satisfactory delivery of sub-contracted services
• Management of designated contracts in accordance with QMS requirements.
• Comply with the requirements of a Trial Master File, including the Sponsor Oversight File, per the study-specific TMF plan
• Conducts all job-related activities according to the QMS and relevant regulatory and guideline requirements

Education and Experience:

• Appropriate undergraduate degree. Postgraduate qualification also advantageous.
• Minimum 6 years’ experience in regulatory affairs within a multi-discipline Pharma or Biotech drug development environment
• Has supported regulatory approval process of therapeutic drugs in either Europe or the US.
• Established relationships with FDA, EMA and/or MHRA.
• Senior management experience in a small or medium company environment
• CNS therapeutic area experience is beneficial, but by no means essential

Skill and Knowledge:

• Detailed knowledge of the regulations and standards applicable to therapeutic drug approval in the US and/or Europe
• Understands the full value cycle of the pharmaceutical industry, including all stages of drug development
• Understanding of the EU Clinical Trial Directive and ICH requirements governing the international pharmaceutical industry
• Fundamental understanding of scientific research methods and thought processes
• Excellent analytical and communication skills
• Proven organisational and people management capabilities

Important Information:

This is a small and incredibly friendly company, with a supportive culture and a team driven by the desire to create drugs that change the outlook for patients and families affected by neurodegenerative disease.

The role will be majority work from home, but candidates must have the ability to travel monthly to the office in Scotland, as well as internationally in the EU and US as required (expenses paid by the company). Relocation support can be provided for candidates considering a move to Scotland.

Salary is negotiable based on experience.

Please apply today and you will receive a call to discuss in more depth prior to application to the client. If you would like to find out more, please contact katie.dunbar@rbwconsulting.com or 01273 952176.