Senior Manager Regulatory Affairs CMC
Offer
- a quality orientated organisation in the pharmaceutical industry
- working in an international environment
- a temporary contract from Derks & Derks Secondment
- a contract for 12 months with the possibility to extend
- hybrid – if possible once a week at the office
Position
As Senior Manager Regulatory Affairs CMC you will play a key role in the Regulatory Affairs department for Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory documents and submissions. You will be responsible for developing and executing CMC regulatory strategies for assigned products, including the preparation and review of CMC documentation for regulatory submissions, such as e-CTD Quality modules, IND/IMPD documentation, and briefing materials for Health Authority consultations.
In this role, you will act as the CMC regulatory lead or Deputy for complex projects/products, providing expert advice to global project teams, task forces, and stakeholders. You will collaborate closely with various departments, including Pharmaceutical Technology, Manufacturing, Quality Assurance, and Business Partners, to ensure compliance with regulatory standards and timelines.
This position offers an exciting opportunity to contribute to the success of global regulatory strategies, manage the preparation of detailed registration packages, and actively engage with global health authorities. In summary, this is a dynamic, impactful role where you can apply your regulatory expertise in a collaborative and international setting.
Profile
- bachelor’s degree in Chemistry, Pharmaceutics, Engineering, or an equivalent field
- at least 8 years of industry experience, with 3+ years in Regulatory Affairs or CMC-related roles
- demonstrated experience with global regulatory aspects of CMC across multiple dosage forms
- proven track record of successful interactions with global health authorities related to CMC submissions
- effective writing skills to meet regulatory requirements and standards
- ability to work independently, manage complex projects, and deliver under strict timelines
- strong interpersonal and communication skills, with fluency in written and spoken English
- experience with additional fields such as biologics, vaccines, or medical devices is preferred
Organisation
The organisation is an international pharmaceutical organisation that has been operating in at least forty countries across Europe, the Middle East and Africa. They operate on a global level and most teams have a global focus. They have everything in house like research, development, manufacturing, warehousing, but also sales and marketing. It is their hope to change tomorrow and to improve the lives of individuals by providing innovative medicines in areas of health where there is an urgent need for better treatments. The organisation is clearly focused on bringing high-quality medicines to the market to reach their goals. At this moment they are open to meet an enthusiastic candidate for a temporary position as Senior Manager Regulatory Affairs CMC at their site in Leiden.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference MSP/24-387 to Luuk Batavier: info@derksenderks.nl. For more information, please call, text or WhatsApp Luuk via +31 (0)6 51981613.
Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
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