Global Regulatory Affairs Manager
vor 1 Woche
Bring your passion. Build the future.
What you will do:
- Lead the joint efforts for the development of the global innovation and product approval strategy in a timely and accurate manner. Prepare Global Regulatory Strategies.
- Manage the Dossiers preparation (e.g. EFSA Feed Additive Dossiers) for product approval/renewals in collaboration with R&D, Product and Project Management, and regional Regulatory Affairs based on the global Regulatory Affairs strategies of DNP.
- Coordinate the submission of dossiers to the regional authorities, together with regional counterparts or registration Consortia, and follow up and support during the review/approval process.
- Work with closely Product Management and production sites to ensure regulatory compliance of your product portfolio and provide regulatory input to the Management of Change process.
- Monitor and report modification of the changing regulatory framework and environment and assess their impact on the business.
- Track the relevant changes and trends in regulations and guidelines and alerts internal stakeholders for relevant strategy adjustments. Contribute to commenting on Guidelines and shaping regulatory framework as appropriate.
- Serve as a liaison between Global Regulatory and relevant Business segment(s).
- Lead the development of DSM opinions in the area of Regulatory Affairs in your area of responsibilities and ensure that they are conveyed to the relevant channels.
- Contribute to the development and maintenance of registration status & planning platforms. Highly contribute to the Regulatory Affairs team performance by taking leadership in development and maintenance of efficient RA tools, processes and coaching of employees and junior colleagues. Contribute to continuous improvement of work processes (e.g. SOPs, software solutions), in collaboration with relevant functions, as appropriate to specific issues.
- Support regional colleagues and Global business for the productspecific aspects (e.g. specifications) in customer Quality agreements or answering customer regulatory/quality requests, as needed.
- Supports issue management related to product quality aspects, e.g. impurity complaints, repeat customer complaints,in close cooperation with all internal function (e.g. Quality Assurance, Marketing & Sales, Product Management) and represent Regulatory Affairs.
We bring:
An environment where you can grow and share your ideas The encouragement you need to develop and achieve your goals Home office work policy and thus a hybrid workplace for your flexibility The chance to shape DSM and its impact for years to come Diverse employees who aren't afraid to think outside of the box A team that truly cares about sustainability, each other, and our customers
You bring:
- University degree in life sciences or equivalent.
- Several years (at least 8 years) of experience in Regulatory Affairs in one or several regulated areas (Feed, Food, Plant protection). Experience with Global Feed legislation is a net advantage.
- Solid to in depth interdisciplinary knowledge in the areas of Analytics, Biological engineering, Chemistry and Fermentation production processes, Biology and Toxicology.
- Strong writing and organization skills.
- Strong persuasive personality, but able to balance and compromise different opinions.
- Strategic and solution thinking skills.
- Precise working style, persistence in pursuing objectives.
- Openminded and good team working skills.
- Fluent in written and spoken English; German, French and any other language is a plus.
About Quality:
No matter which team you are on, at DSM you'll be part of a powerful shared purpose - to create brighter lives for all.
You'll get opportunities to work collaboratively with different departments and industry experts to make a positive difference to the future of millions of people and the planet we all share.
Together, we'll understand the needs of every customer and offer solutions that promote their success and impact, today and in the future.
How to apply?
Royal DSM is an equal employment opportunity and
affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, or any other characteristic protected by law.
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