Manager to Sr. Manager, Regulatory CMC

PharmaLex[RK1] is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asian offices, we provide integrated drug development services through a complete range of offerings including regulatory strategy and operations, quality management and compliance, pharmacovigilance and lifecycle management. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.

We are currently looking for a Senior Manager, Regulatory CMC to be based in the US to support all regulatory projects with specific emphasis on FDA. 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.

As a Key Contributor you will provide a wide range of flexible regulatory affairs services for different clients on a range of product types and therapeutic areas.

• Provide leadership and knowledge-based support for biologics and small molecules CMC activities (e.g. strategic advice, authorship, compilation and review of dossiers; gap analysis; risk mitigation and remediation recommendation, comparability exercises)
• Provide project management for regulatory activities in close collaboration with other technical teams and the regulatory affairs team
• Manage clients and other stakeholders
• Work with the Director CMC US to support business development and implementation of the PharmaLex US REG Affairs and CMC growth strategy including support for proposals writing and work estimates
• Provide critical technical review of documentation based on established experience
• Provide effective consulting support for CMC biologics and small molecule products contributing to the development and implementation of client’s regulatory CMC strategy
• Support client’s regulatory agency meetings, including meeting and briefing book preparation
  
  

Required Education, Experience, Skills And Competencies

• Bachelor’s degree in chemistry preferably with a higher degree in a pharmaceutical related discipline, and 10+ years experience, or equivalent combination of advanced education and experience
• Minimum of 7 years of related “hands on” CMC pharmaceutical development or regulatory experience in CMC in the Pharma or Biotech industry
• Established experience in regulatory affairs activities including:
• Module 3 IND/IMPD authoring and review
• DMF and Module 3 and 2.3 authoring and reviewing for NDAs, ANDAS, BLAS and biosimilars
• Development of CMC regulatory strategy for phase appropriate filling of DMF, MFs, NDA, BLAs, ANDAs and Biosimilars, INDs and IMPDs
• Scientific advice procedures
• Submission management
• Experience with different territories, authorization procedures and health authorities, with emphasis on FDA experience
• Experience with development and life-cycle management of products
• Experience in regulatory affairs and understanding of GMP requirements for manufacturing, quality systems, process, analytical
• Structured, analytical, systematic, focused, and able to deliver high-quality work
• Strong work ethic and proven adaptability to meet client needs
• Excellent written, verbal and presentation communication skills
• Ability to work in a team. Ability to adapt under regularly changing conditions
• Outstanding organization, analytical, and problem-solving skills
• Strong sense of responsibility
• Work with client to resolve issues/problems, responding to requests in a timely manner
• Manage client relationship when there are changes in scope or the project plan
• Maintain meaningful relationships with clients after project is completed, keeping PharmaLex business development appraised
• Actively seek out new client relationships/new business opportunities on behalf of PharmaLex
  
  

Travel expectations (in %): Up to 20%

This is a remote position

[RK1]Are we updating this to Cencora?

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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