Emergency Access to Medicines - Regulatory Access Associate - (Remote Position)

Client Services · Remote, Middlesex
Department Client Services
Employment Type Permanent - Full Time
Minimum Experience Mid-level

WHO WE ARE


At Caligor Coghlan Pharma Services ("CCPS"), our mission is to partner with pharmaceutical, biotechnology, and medical device clients to help bring new, life changing medical products and treatments to people in need across the world.

 

We feel good about the work that we do – as a global company, our services include clinical trial design, clinical packaging and labeling, medical product management and global distribution, commercial and ancillary product procurement, and Early Access to Medicines services.  We pride ourselves in making it our business to find a better way to deliver for our clients - and the patients they serve.  Our dedicated people care - about their work, their team, and the results we strive to deliver every day. We expect all of our people to live and work our corporate values of *Integrity*People*Quality*Service*Expertise*Accountability*

 

If you are looking for a role that leads in the types of endeavors listed above in the world of Pharma Services, where what you do and how you do it will make a difference, then this key role of Regulatory Access Associate may be for you.


WHAT YOU WILL DO


Regulatory Access Associate - EAM


The Regulatory Access Associate will support the Early Access to Medicines (EAM) Business Unit. This role also provides day to day assistance to approve shipments to ill patients, and will provide the opportunity to learn regulatory requirements for Early/Expanded Access Programs and lend strategic support. 


Organisational Position:

The position reports to Global Director of Client Services and has no direct reports.


Communications and Relationships

In additional to being part of the EAM Team, you will work in collaboration with departments such as Quality, Logistics and Finance, as well as regulatory bodies, clients and company vendors. 


Duties:

  • Provide Regulatory Green Lights for shipments for EAM activities
  • Support the EAM team with review of shipment requirements
  • Interact, develop and maintain relationships with global regulatory bodies and internal and external stakeholders
  • Assist with Global Regulatory Intelligence research and maintenance of internal database including information collection, review and catalogue filing of data

Qualifications:

  • Bachelor’s degree in life sciences
  • 2-3 years pharmaceutical or Contract Research Organisation (CRO) global clinical trials experience working in a similar role
  • Effective communication and organizational/time management skills
  • Flexibility, open mindedness and adaptability to a rapidly changing regulatory environment
  • Enthusiastic individual with superior interpersonal skills and investigative mindset
  • Excellent written and oral communication skills

Experience/soft skills:

  • Ability to understand and summarise legislation in order to choose and implement the appropriate regulatory steps for an Early Access Program
  • Ability to develop and maintain global regulatory knowledge
  • Working knowledge of all MS suite of products (Project, Visio, Power Point, Excel and Word)
  • Proven understanding of principles, and implementation and maintenance of Good Clinical Practices and regulations


Thank You

Your application was submitted successfully.

  • Location
    Remote, Middlesex
  • Department
    Client Services
  • Employment Type
    Permanent - Full Time
  • Minimum Experience
    Mid-level