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