Senior Global Regulatory Executive job in Waltham, USA

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Job type: Permanent

Discipline: Senior/Director & VP, Publishing & Submissions

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for Senior Global Regulatory Executive with a pharmaceutical company located in Waltham, MA and Collegeville, PA.

Job Responsibilities:

Support to Regional Regulatory Therapeutic staff for submission of project-related information to Regulatory Agencies per agreed timeframes to maintain regulatory compliance for existing drug marketing licenses
Responsible for coordination, preparation, review and delivery of routine regulatory submissions, ensuring quality of own work and monitoring quality of contributing group deliverables to comply with GRA processes and standards, ensuring GRA submissions comply with regulatory guidelines and within required timelines, ensuring compliance with archiving of regulatory information in databases, may be required to liaise with Regulatory Agency representatives in response to queries or information requests, provide ongoing regulatory document retrieval and assessment
Proven written and verbal communication skills required to deliver communications with credibility and clarity, sound interpersonal skills, capability to work flexibly across different areas of medicines and teams, potentially managing multiple submissions simultaneously, sound problem solving skills, ability to build effective working relationships, ability to interpret and advise on guidelines and requirements

Skills and Requirements:

Advanced degree in life sciences, or related discipline
Regulatory Strategy experience is a must
Strong expertise in Global RA
Background in Oncology and Immunology preferred

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 Sarah Beshara at 267-477-3355 or upload your resume 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.

Proclinical Staffing is an equal opportunity employer.

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