Regulatory Specialist

An internationally leading pharmaceutical company is seeking to recruit a Regulatory Specialist to their office in Massachusetts. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.

Job Responsibilities:

• Manage FDA submissions to the Office of Prescription Drug Promotion (OPDP).
• Support US Review Committee (USRC) as lead for specific brand projects and designated reviews.
• Manage operational aspects, including OPDP submissions, for brand and campaign launches.
• Track OPDP correspondence and drafts responses to advisory comments or enforcement actions for GRA Ad-Promo leadership review.
• Lead US Regulatory training initiatives (including research, development and presentation of training).
• Work in partnership with Marketing Effectiveness and other business partners to identify communication gaps and opportunities for internal training.
• Responsible for monitoring and communicating FDA enforcement actions
• Maintain strong competitive intelligence tracking and provide strategic input to our business partners regarding industry trends.
• Participate in Regulatory team meetings, brand team meetings, launch meetings, GRA Ad-Promo team meetings, and additional meetings as requested.
• Ensure that unresolved issues are escalated as needed and provide thoughtful solutions at the appropriate level.

Skills and Requirements:

• BA, BS/BSc, or PharmD.
• 2 years of direct bio/pharmaceutical experience in a related aspect of drug development (late staged preferred) or direct experience with advertising and promotion communications.
• Foundational knowledge of FDA regulations, guidance and enforcement trends to provide Regulatory guidance on a project basis as part of USRC.
• Developing understanding of how to interpret complex scientific data as it relates to regulatory requirements for product or disease state communications.
• Basic understanding of scientific principles and regulatory/quality systems relevant to drug development.
• Proficient in proofing materials for OPDP submission and can conduct cross-brand analysis as requested.
• Basic understanding of current social media platforms and available communication technology.
• 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 Sherron Howard at +1 267 435 8600 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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