Senior Regulatory CMC Manager / no-609

Status: 
closed
Location: 
4070 Basel, St. Johann
Start Date: 
2018-07-02
End Date: 
2019-07-31
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
1.056
Assignment: 

Background

For our Swiss customer located in Basel, St Johann we are currently looking for (m/f) a Senior Regulatory CMC Manager

•    Type of placement:  12 months, external contract with possible long term extension
•    Company:  major Pharma company in Basel area
•    Salary:  level 1, please ask us for the exact rate range 

(monthly all in salary levels in CHF,  level1= 5-10k , level2=10-15k,  level3= >15k)

Job Description and Purpose:

Independently, provide strategic and operational global CMC regulatory direction and documentation for projects/products within responsibility covering development, registration and approval/post approval activities as assigned. 

Major Activities 

The following tasks are to be performed as assigned: 

  • Formulate, lead and drive global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance. 

  • Proactively communicate CMC regulatory strategy, key issues and any other critical top-ics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in regulatory, technical development and technical operations departments as appropriate. 

  • Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions. Make quality regulatory decisions, balancing risks and benefits. 

  • As early as possible, identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved tech-nical source documents in accordance with project timelines. 

  • Author high-quality CMC documentation for HA submission, applying CMC global regula-tory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. 

  • Establish and maintain a single point of contact with FDA or country affiliates, RA re-gional and TA groups for all communication on development and marketed products. Es-tablish and maintain sound working relationships with partners and customers. 

  • Initiate and lead Health Authority interactions and negotiations as appropriate; setting ob-jectives, preparing briefing books, coordinating and planning rehearsals and risk mitiga-tion plans. 

  • Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for as-signed development projects and/or marketed products, and prepare CMC responses, as appropriate. 

  • Lead, prepare and communicate CMC risk management assessments (RMA), contingency plans and Lessons Learned exercises on major submissions and escalate to manage-ment as appropriate. 

  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends. 

  • Represent own department on due diligence teams for in-licensing and divestment op-portunities. 

  • Represent own department on teams for continuous improvement within the department. 

  • Provide advice and direction within the department within specialized assignments as as-signed. 

  • Represent own department at Global Supply Support Teams (SST), Regulatory review boards and other teams and boards as appropriate. 

 

Ideal Background 

Education (minimum/desirable): 
Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent 
Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. 
Languages: Fluent English required (oral and written). 
Good skills in site (local) language desired (oral) (German) 
 

Requirements: 

Experience/Professional requirement:

  • Minimum 4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals 
  • Working knowledge/experience in regulatory submission and ap-proval processes for new chemical entities (NCE) and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements. 
  • Proven track record of successfully working in interdisciplinary teams and planning, coordinating and leading activities simultane-ously on multiple projects. 
  • Regularly demonstrated active contributions to line functions or pro-ject teams, as well as ability to contribute to matrix teams with the necessary strategic thinking. 
  • Demonstrated ability for strategic thinking, maintaining awareness of business impact. 
  • Demonstrated ability for risk assessment and mitigation. 
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload. 
  • Effective planning, organizational and interpersonal skills. 
  • Excellent written/spoken communication, negotiation skills and problem solving skills. 
  • Computer literacy