Senior Regulatory Affairs Consultant

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small. In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace. Full Time Travel: Yes Glassdoor Reviews and Company Rating Success Profile Check out the top traits we're looking for and see if you have the right mix. Detail-Oriented Proactive Problem-Solver Results-Driven Organized Multi-Tasker Rewards Global Impact We are one truly global team working together to propel each client´s journey ahead faster. Balance We value work-life balance. We try and keep regular hours and an emphasis on life outside the office. Collaboration Work with industry leaders and subject matter experts. Freedom The ability to innovate, ask “what if” and try new solutions without fear of failure. Variety Opportunities to work on multiple accounts – never boring! Management Strong management with depth of experience working for global health authorities. Expertise/Experience Subject Matter Expert in Submission writing/Technical writing pertaining to Pre-Investigational New Drug authoring(IND), IND/IMPD authoring and/or New Drug Application (NDA)/Biologics License Application (BLA) Reviewing/Preparation of the clinical regulatory documents for Innovator products (new filings/hybrid filings) listed below, not limited to: Briefing documents/meeting packages General investigation Plan Investigator Brochures CTD modules such as Module 2.5 (Clinical overview), Module 2.7(Clinical summary and tabulations including Summary of Safety (ISS), summary of Efficacy (ISE) Preparing/reviewing responses to heath authority queries Educational background Masters in pharmacy/PhD/BDS/MBBS, advanced degree preferred Around 15 years of overall experience in Industry/regulatory domain with knowledge Biologics/Biosimilars Therapeutic area knowledge : Oncology, Immunology, Cardiovascular, targeted therapies etc. #LI-REMOTE