CMC Project Manager
- Permanent, Full-time
CMC Project Manager
Our client Aquilon Pharmaceuticals is a company active in the development of innovative drugs in the respiratory field. As the company is growing, they are currently looking for a Project Manager (CMC)
The successful candidate will contribute as Project Manager to the development and execution of Regulatory CMC strategies, submissions and compliance activities from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD’s, MAA’s,…) to regulatory agencies.
As Project Manager (CMC) you will also:
- Undertake the full responsibilities for the development of products (planning, coordinating and supervising the activities of products developed by external centres and reporting their progress to the Management, other departments and partners), including leading and directing the formulation development,
- Ensure that R&D department meets the timelines and manage delays, negotiate delivery time and cater efficient information flow between internal and external teams,
- Plan and negotiation of Project budgets and assessment of appropriate project scopes.
- Manage external providers related to the CMC activities.
- 10 years of working experience in a similar position (or in a Regulatory Affairs position)
- University level education (Master or PhD), with a scientific background
- Experience in the health sector, with excellent understanding of policy and regulation in pharmaceutical and/or medical devices strongly desired
- An additional experience in formulation developments is an asset.
- Good understanding of the product development process from formulation to registered batches manufacturing
- Good knowledge of the regulatory requirements (i.e. GMP and additional regulatory requirements from EMA and/or FDA) allowing successful registration with the authorities.
- Given that most of the new developments are targeted for the EU&USA, experience with EMA and/or FDA requirements is a must.
- Excellent knowledge of English (both spoken and written); with fluency in French being an asset
- Strong interpersonal skills with the ability to influence others in a positive and effective manner
- Demonstrated ability to contribute to a continuous learning and process improvement environment
- Proven track record in product management or equivalent with knowledge of product management techniques and tools.
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
- Ability to understand and analyze scientific data and results and review scientific documents including drug development reports, publications and regulatory submissions.
- Strategic thinking, strong problem-solving and analytical skills
- Understanding the scientific principles and regulatory requirements
- Communication and motivation skills
- Ability to work in a team
- Detailed oriented
- Strong sense of planning and prioritization
- Good understanding of and respect for cultural differences and the capacity to work effectively in a multicultural environmen
- Stimulating challenges in a flexible & fast growing Start-up
- Expert and passionate colleagues with friendly working surrounding
- Career growth as the company grows
- Autonomy and independence
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- Master (University or Higher Education Long Type)
- At least 5 years experience
- English, French
- 19 August
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