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.
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.
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)
- 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