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PharmaLex is one of the largest providers of Development Consulting and Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech and MedTech industries to help them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch.
We are currently looking for a Manager to Senior Manager, Regulatory CMC to support our Regulatory Affairs team. The level will be commensurate with the candidate experience. Candidates should be dependable self-starters who bring with them a high level of ownership over their work, an enthusiastic attitude, and a collaborative mindset to support our efforts to provide regulatory and development consulting solutions for pharmaceutical and biotech companies of all sizes.
PharmaLex is a proud to be an equal opportunity employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skill, and experiences within our workforce. We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
As a Key Contributor You Will be accountable for the execution of operational as well as managerial tasks in the field of Regulatory CMC. Requires established experience and specific scientific expertise in the sector of human and veterinary medicinal products with special emphasis on the relevant US and Canadian regulatory requirements.
Reports to (title): Director CMC US
Number of direct/indirect reports: None
Travel expectations (in %): Up to 20%
Location: Remote, US Mainland
Manager to Sr. Manager, Regulatory CMC
- Contribute to the development and implementation of client’s regulatory CMC strategy.
- Lead gap analysis projects for client to identify gaps and propose mitigation strategies.
- Lead initiatives for project and timeline management in support of regulatory CMC objectives and projects.
- Author high-quality CMC regulatory submission content of the to support global clinical development, registration, and product life cycle management (INDs, IMPDs, DMFs, ANDAs, NDA/BLA, QOS, etc.)
- Manage regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, change controls, etc.
- Contribute to business development efforts including proposals and work estimates.
- Actively participate/lead regulatory CMC infrastructure and capability building, including developing best practices, training tools, and cross-program learning.
- Consult with and provide guidance to PharmaLex staff and customers regarding quality aspects from drug development up to life-cycle management.
- Develop risk-based CMC strategies following cGMP for 21st Century initiatives and Quality by Design (QbD) principles
- Prepare CMC relevant sections of informative texts for healthcare professionals and patients (SmPC, CCDS, PL, labelling).
- Provide Regulatory agency meeting support including meeting preparation and briefing document creation.
- Perform technical database, internet and literature searches with preparation and evaluation of the search results, review, and evaluation of technical literature.
- Present seminars and lectures internally, for customers and for professional audience with emphasis on quality aspects
- Perform project management tasks, e.g., milestone and budget planning.
- Other duties as assigned
- Bachelors’ Degree in Chemistry or Life Sciences, advanced degree preferred, and 3 to 5+ years’ experience, or equivalent combination of education and experience
- Minimum of 3 to 5 years of related “hands on” drug development experience in CMC with strong module 3 writing experience.
- Lead extensive project reengineering activities and provide consultation related to change management
- Experience with chemical and biological (Active Pharmaceutical Ingredients and or Drug Products)
- Ability to translate strategic goals of partnerships/customers or internal projects into tactical goals
- Ability to lead project teams including supervision, prioritisation and processing of parallel projects and tasks
- Ability to discuss and align mid-term goals of collaboration on level of client’s department heads
- Structured, analytical, systematic and independent manner
- Ability to adapt under regularly changing conditions
- Outstanding organization, analytical, and problem-solving skills
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.