Associate Director, Regulatory Operations - Amsterdam, Netherlands (Remote flex)

SUMMARY

Are you a hands-on qualified regulatory affairs professional with a broad interest for divestment projects? In this role you are able to play a key role in an international organization and influence and coordinate the scientific and regulatory strategy.

RESPONSIBILITIES

This position plays a key role in the regulatory affairs department. You are independently responsible for multiple regulatory functions and can be a member of one of several regulatory groups. In this role you

• Develop challenging strategies for new assignments outside of existing regulatory.
• Are the manager who drives submission related activities.
• Execute regulatory strategies successfully.

The role is highly analytical and complex; you work on strategic, diverse problems, with decision making that has functional or corporate impact. You need to influence and communicate clearly, as actions may have serious implications on operations, revenue, and/or credibility. In this position you anticipate regulatory issues for assigned projects and manage them proactively.

As an associate director you represent the operational status of the products and you will go through the whole life cycle and the execution of submission. Working for a global organization; you will interact with a multi-cultural environment and you need patience and coordination. There is a huge opportunity to learn about regulations and procedures in multiple countries in a complex field, together with a multi-diverse team.

You will work in the field of small molecules and you provide drug and/or drug-device expertise in directing projects within these therapeutic areas. The role includes contact with Health Authorities, Affiliates, International Regulatory Support, Clinical and Medical affairs, PharmacoVigilance, Chemistry Manufacturing and Controls (CMC), Advertising/Labeling, Regulatory Operations and to the Global Project Team. 

QUALIFICATIONS

• Bachelor’s degree in scientific discipline; advanced degree preferred.
• 9 years previous pharmaceutical life-cycle management experience. 
• 6 years regulatory affairs experience preferably involving direct contact with the Health authorities such as EMA, FDA, and/or PMDA; full knowledge of country/regional and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
• High experience in divestment projects worldwide developing regulatory strategies and the execution. Experience in due diligences processes and in writing/reviewing agreements is a must.
• Experience in planning and executing MA withdrawals worldwide is a plus.

You have strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to direct reports and others in the department as needed. As a multitasker you have the ability to communicate effectively and maintain effective working relationships. You must be able to have a positive influence on the department staff and behave with a high integrity. The role needs an excellent writer and oral communicator, to meet the regulatory requirements and standards.

DURATION

6-12 month contract / full-time (40 hours a week) – possibility of extension or converting permanently

SALARY

Attractive hourly pay rate

LOCATION

Leiden, Netherlands

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

Please click ‘apply’ or contact Sam Chapple at Planet Pharma for more information:

E: schapple@planet-pharma.co.uk

T: +44(0)203 868 8607