Regulatory CMC Manager/Senior Manager (Development)

26 June 2019

AUTHOR: Antony Appleyard



Reports to: Associate Director Regulatory Affairs
Contact: careers@diamondpharmaservices.com

Based at: Harlow UK

Job Description

The Regulatory CMC Manager/Senior Manager Biologics provides development stage advice to internal staff and to clients for a broad range of programmes. They will possess a strong understanding of existing and leading-edge technologies and be able to speak knowledgeably about client programmes. They will provide the following expertise-based services:

  • Point of contact for agency interaction
  • Provide expert EU regulatory strategy
  • To be a client lead
  • Provide leadership in scientific advice meetings at national agencies and EMA
  • Project management/lead responsibilities
  • Client facing with strong communication skills, willing to travel
  • To assist the company in providing regulatory knowledge to business development colleagues during bid defence
  • Provide expert CMC advice and writing services for IMPDs/INDs

Key Responsibilities and Duties of the Role

  • Provide EU regulatory affairs and CMC advice to clients developing a wide variety of medicinal products
  • Lead client related activities for IMPD and/or IND writing
  • Provide expert EU regulatory strategy
  • Regulatory lead and point of contact for national agency and EMA interactions
  • Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.
  • Provide development related strategy for a broad range of programmes
  • High level of client focus and accountability
  • Assist with Business Development activities by taking part in new prospective client-lead discussion

Professional Experience

Essentials

  • Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines
  • 3+ years CMC regulatory affairs experience with demonstrable experience in liaising and negotiating with regulatory authorities
  • Demonstrable experience in scientific advice meetings from a CMC perspective
  • Demonstrable experience of writing the CMC sections for IMPDs or INDs
  • Strong understanding of the regulatory environment including guidelines
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Excellent computer skills
  • Collaborative approach and able to work effectively with matrix-based teams involving internal staff, client teams that include independent consultants

Preferences:

  • >5 years of experience in regulatory affairs based activities and regulatory authority interactions
  • US FDA facing experience
  • Past experience in technical CMC or pharmaceutical/biologics development would be an advantage

Personal Attributes

  • Innovative and pragmatic problem solver
  • Attention to detail
  • Strong communicator with the ability to influence
  • Completer-finisher able to provide decisive leadership in a project team setting
  • Ability to provide a flexible, proactive and dedicated approach whilst dealing with clients with different working styles and cultures.
  • Strong client focus

General Responsibilities and Duties of the Dept

Diamond BioPharm Limited is the Regulatory function within Diamond Pharma Services. The function provides end to end regulatory services and expertise driven product development advice from early stages of development through to post market support. Our regulatory division are experts in all aspects of European regulatory affairs providing support to clients in the following areas:

  • Writing product development plans and providing gap analysis
  • IMPD/IND writing
  • Technical CMC support
  • Preparing orphan applications, PIPs and PRIME submissions
  • Assisting with scientific advice procedures
  • Clinical Trial Application submissions
  • GMO applications
  • Ethics submissions
  • Assistance in preparing and submitting variations and Marketing Authorisation Applications through the various Regulatory Authority procedures
  • Acting as an overflow Regulatory Department