JOB-RELATED INFORMATION

This document includes information about the role for which you are applying and the information you will need to provide together with your CV and covering letter.

ROLE DETAILS

Job Title:

Associate Director of Regulatory Affairs

Reports to:

Heidi Petersen (Sr. Vice-President of Regulatory Affairs)

Salary Range:

Competitive in industry

Duration of Post:

Full Time

Working Hours:

35 hours per week, with some occasional out-of-office hours according to company needs

Location:

London Office (at least 3 days in office and optional up to 2 days working from home)

How to Apply:

CV and detailed covering letter stating salary expectation and details of right to work in the UK

 

 

Recruitment Contact:

jointheteam@mereobiopharma.com

 THE COMPANY

Mereo is an international, clinical-phase biotech company with a focus on rare diseases and oncology.  Our vision and mission are to bring safe and effective first-in-class treatments to areas of high unmet medical need.  Founded in 2015, we currently have 3 development programmes, in oncology and rare diseases.  These are : i) an anti-TIGIT being investigated in a range of rare tumours and gynonc tumours ii) a neutrophil elastase inhibitor being investigated in the rare disease Alpha-1 Anti-trypsin Deficiency and iii) an anti-sclerostin antibody being developed for the rare disease osteogenesis imperfecta by our partner Ultragenyx Pharmaceuticals We aspire to harness the energy, drive, commitment and focus of a small company to build value into all our programmes and to work closely with all stakeholders in order to accomplish this.  Our headquarters are located at Cavendish Place, London, UK, where this role is based, and we have colleagues based on the East and West Coast in the US More information is available on our website at:  www.mereobiopharma.com.

 CURRENT COMPANY SET-UP

This role will be based in the Company’s HQ office in London and Mereo will continue to adhere to the UK/US Government’s guidelines regarding working practices under the current COVID pandemic situation, adapting our working practices accordingly.

As the UK has begun to reopen in line with the vaccination program, Mereo staff are currently attending the office on alternate days with social distancing and other measures in place (including rapid testing) due to Covid 19 restrictions.

 THE POST

Purpose of the Associate Director of Regulatory Affairs role:

We are looking for an enthusiastic, skilled, experienced, and motivated professional to join the team. 

 

The candidate will report to the Sr. Vice-President of Regulatory Affairs and will have primary responsibility for activities pertaining to regulatory strategy and submissions to the EMA, FDA and other Health Authorities.  In particular, the candidate will have in-depth experience with submissions to the EMA and country-specific health authorities within the EU and non-member states.  The candidate will also have in-depth experience with interacting with regulators.

 

Main Responsibilities:

  • Responsible for managing activities of Regulatory Affairs with emphasis on global regulatory strategy and the preparation, review and submission of documents to EMA, FDA and other regulatory authorities
  • Provide regulatory advice to multidisciplinary teams on the regulatory requirements to support clinical and nonclinical development, including preparation and maintenance of CTA and IND fillings
  • In collaboration with team, perform/manage critical analyses of GXP related data and independently develop strategic/tactical interpretation and implementation
  • Lead multidisciplinary teams in the development and authoring of major regulatory documents such as Briefing Package and IMPD
  • Coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, Investigator’s Brochure, clinical study reports)
  • Facilitate and as needed, lead activities (including team preparation) for meetings with EMA, FDA, and other regulatory authorities
  • Interface with global regulatory authorities and consultants as needed
  • Manage the regulatory aspect of the pediatric program and development activities internally
  • Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks
  • Oversee and ensure compliance with regulatory procedures and work practices
  • Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the team
  • Train, mentor and supervise regulatory employees, consultants/contractors in Regulatory Affairs. Maintain a positive team spirit and lead by ethical principles

 THE PERSON

NOTE:  Applicants who have not clearly demonstrated on their CV that they possess the essential experience and knowledge will not be short-listed.
Desirable elements are those that is would be useful for the post-holder to possess and will be used to assist the short-listing process where we receive a large volume of highly qualified applications. The skills, capabilities and qualities section will be assessed during the interview process.

Essential

Desirable

Education, Qualifications & Training

  • Master’s degree in science within a relevant scientific discipline required;
  • Pharm. D, Ph.D. preferred

Languages

  English

Knowledge & Experience

  • Minimum of 10 years of experience working in the pharmaceutical/biotechnology industry with direct extensive experience in Regulatory Affairs
  • Demonstrated experience in the preparation and submission of CTAs, INDs and NDAs/BLAs
  • Experience with Paediatric Investigation Plans (PIP), Pediatric Study Plans (PSP), and other pediatric regulatory aspects preferred
  • Expert knowledge with GXP/ICH requirements and Guidance in major markets, especially EU and US

 

Skills, Capabilities & Qualities 

  • Excellent written and verbal communication skills. Strategic thinker, planner with excellent organizational skills
  • Flexibility to wear multiple hats as needed
  • Proven ability to effectively work collaboratively in cross functional teams

 

Excellent IT skills, including Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, etc.)

Must be IT competent and have a knowledge of data protection.

 THE APPLICATION PROCESS & WHERE TO SEND COMPLETED APPLICATIONS

Please send your CV and covering letter to jointheteam@mereobiopharma.com with the job title included in the subject line.

If you do not hear from us within 2 weeks of the closing date, you should assume that your application has been unsuccessful on this occasion.