Director, Regulatory Affairs

A vacancy has arisen for a Director, Regulatory Affairs with an internationally renowned pharmaceutical company, based in their office in Cambridge. This organisation is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organisation and support their innovative impact on the healthcare field.

Job Responsibilities:

• Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidances are met for assigned product(s) and territories.
• Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
• Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations, for assigned product(s) and territories.
• Responsible for ensuring any updates to the CCSI and CCDS are implemented for assigned products in assigned territories in a timely manner.
• Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories.
• Represents the Regulatory Function at internal and external meetings.
• Work proactively to build contacts with local Regulatory Authorities and participates in industry trade groups and regulatory affairs professional societies, as required.
• Maintain knowledge of regulatory requirements, contributes to preparation of new regulatory guidance wherever possible, and communicates changes in regulatory information to project teams and senior management in a timely manner.
• Deputize effectively and reliably for Executive Director International Regulatory Affairs within the Company and with Regulatory Authorities.
• Develop and implement training of Regulatory Affairs staff and other R&D staff as required.
• Initiate or contribute to global process improvements which have a significant impact on the business.

Skills and Requirements:

• Requires a Bachelor's degree in a relevant discipline (an advanced degree is highly desirable), with Extensive Regulatory Affairs experience.
• Oncology/biotechnology research or drug development experience highly desirable.
• Previous people management experience in a Regulatory Affairs environment.
• Experience working with Regulatory Authorities in assigned territories is required.
• Experience representing Regulatory Affairs at Agency Meetings is mandatory.
• Must be well versed in regulatory requirements, including ICH requirements and regional requirements for assigned territories, and have an astute understanding of current global and regional trends in Regulatory Affairs, and ability to assess the impact of these requirements on the business.
• Must have a demonstrated understanding of business needs, and a proven ability to consistently assess resource requirements, and manage staff recruitment.
• Must have a proven track record of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities and demonstrate a proven track record of excellent influencing and negotiating skills.
• Must demonstrate the ability to lead Regulatory and Company teams, in preparation of submissions and maintenance of licenses, (via direct reports or matrix management).
• Must have significant cross-functional team experience including but not limited to interactions with Medical Affairs, Commercial and Market Access.
• Experience in the review of promotional material, including promotional material for both national and international marketing congresses is desirable.
• Demonstrable multitasking, project management, and execution skills.

• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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