CMC Regulatory Affairs Professional
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.The Role
In order to strengthen the Regulatory Affairs team, we are looking for an experienced CMC Regulatory Affairs professional who will be based in Copenhagen.
As CMC Regulatory Affairs Professional, you will be responsible for operational and strategic regulatory input with an emphasis on CMC matters to support worldwide development and commercialization of the Genmab pipeline. You will be part of the operational teams directing and coordinating international regulatory submissions supporting the conduct of clinical trials. Furthermore, you will be supporting marketing authorization submissions to EMA and other regulatory health authorities.
You will report directly to Vice President - Head of Global Regulatory AffairsKey Accountabilities
- Develop and execute sound and robust global regulatory CMC strategies for Genmab biologic drug products at various stages of development
- In collaboration with the Regulatory team, provide direction and guidance to the project development team to ensure high likelihood of regulatory approvals
- Proactively, and in a timely manner, evaluate and communicate regulatory risks and challenges, and propose ways to mitigation to the project team and senior management
- Prepare and manage the regulatory CMC sections of clinical applications (IND and IMPD), Health Authority briefing packages, marketing applications in selected markets, and responses to agency requests
- Update and maintain the CMC documentation submitted to Health Authorities to ensure compliance
- Provide advice and guidance on EU, US, and selected WW regulatory legislation for CMC topics and initiatives as they apply to Genmab projects/products
- Be a member of Project Task Force teams and ad hoc member of Project Core teams
- Liaise and collaborate with Manufacturing and Quality Assurance groups within Genmab for CMC regulatory issues
- Liaise with Authorities for CMC regulatory issues and represent Genmab at meetings and interactions with Health Authorities for CMC regulatory topics/issues
- Contribute to establishing and administering internal regulatory policies and procedures to achieve best practices work processes including writing SOP’s
- Collaborate with cross-functional peers to facilitate and optimize the product development and registration process including writing of regulatory documents
- Stay abreast of newly issued regulatory laws and guidance as well as technical publications, articles, and abstracts in order to promptly identify possible impacts or improvements to product programs
- Participate in professional and industry organizations to follow regulatory trends, influence development of regulations and guidance, and develop relationships to represent the interests of the company
- You have minimum 4-5 years of experience with the regulatory CMC area as well as a good understanding of compliance and biologics.
- You have experience working directly with global health agencies on regulatory matters.
- You have a successful track record in moving therapeutic products through various stages of development and approval as well as proven experience developing short- and long-term regulatory strategies to rapidly deliver innovative products to the market.
- You should be adept at formulating and driving strategy, tactically oriented in preparing and writing submissions, and be proficient in a hands-on role.
- You also have the ability to collaborate effectively with multiple functions including research, development, clinical, and quality.
- You have a relevant university degree - preferably a Master of Science in Pharmacy, Engineering, or Chemistry.
Moreover, you meet the following personal requirements:
- You are a person who thrives on being challenged and working collaboratively.
- Strong interpersonal skills and possess the ability to communicate with other development staff in a fast-paced setting.
- You are comfortable in a dynamic environment in which priorities and drivers can change rapidly and you have the ability to think and manage strategically with attention to detail.
- You are pragmatic, robust, and able to stand firm.
- You have a high energy level and a passion and sense of urgency for developing important new medicines for devastating diseases.
- You are able to travel to CMO and partner sites (up to 10-15% per year)
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful applicant a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
If you would like additional information about this position before applying using the link, please contact Uthen Khamproh (email@example.com)
Genmab has selected Korn Ferry as a global recruitment partner to help us manage your application. When uploading your application it will be transferred to Korn Ferry for their processing. By clicking ‘apply now’ you will see how Korn Ferry manages your application and privacy.
To learn more about Genmab, you can visit our website: http://www.genmab.com/