Director, Regulatory Strategy - Immunology
Director, Regulatory Strategy - Immunology
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Job Description
Galderma is the emerging pureplay dermatology category leader present in approximately 90 countries. We deliver an innovative sciencebased portfolio of premium flagship brands and services that span the full spectrum of the fastgrowing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ the skin meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.
We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.
At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.
As our Director of Regulatory Strategy Immunology you will drive the global regulatory strategies for all indications for Nemolizumab and ensure regulatory submissions are complete compliant and performed per agreed timelines.
The role partners closely with key stakeholders within the Global Regulatory Affairs teams as well as cross functional leads and external partners and directly reports to the Head of Global Biologics Regulatory Strategy.
Summary of Job Responsibilities
Accountable for global regulatory strategies and global submission plans for AD PN pCKD and any newly identified indications
Lead for AD: responsible for global regulatory strategy & submission plans for AD
Coordinate regulatory CMC strategies with RA CMC
Accountable for US regulatory strategies for all indications in coordination with indication leads
Primary contact for FDA
Lead Nemolizumab global regulatory affairs team establishing team goals norms responsibilities and communication plans
Identify and assess risks associated with product development and recommend strategies to mitigate these risks
Provide regular updates to leadership Nemolizumab product strategy team and project lead
Ensure strategic regulatory input is provided to key development activities and documents including clinical nonclinical and CMC development documentation as needed
Minimum Requirements:
BSc MSc or PhD in a Scientific discipline or Pharmacist
Minimum 10 years experience in pharmaceutical/biotech and NCE development Regulatory Affairs
Minimum 10 years experience in the preparation and submission ofINDs CTAs NDA/BLAs or MAAs
Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US and EU)
Experience with communicating the regulatory strategy issues and risks in written and verbal format to regulatory senior leadership team and other governing bodies
Experience interfacing with regulatory agencies and skill at implementing successful global regulatory strategies
Experience with documenting regulatory strategies in coordination with clinical plans and marketing objectives.
Excellent team interaction skills along with demonstrated ability to work on a crossfunctional team
Experience with international project management
Focused on effective delivery of objectives even when working with tight deadlines
Ability to identify opportunities/major issues and to communicate impact
Demonstrated ability to deal with rapid change
What we offer in return:
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits including a competitive wage with shift differential annual bonus opportunities and career advancement and crosstraining.
Next Steps:
If your profile is a match we will invite you for a first virtual conversation with the recruiter.
The next step is a virtual conversation with the hiring manager
The final step is a panel conversation with the extended team
Our people make a difference
At Galderma youll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism collaboration and a friendly supportive ethos is the perfect environment for people to thrive and excel in what they do.
Employers Rights:
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract and either you or the employer may terminate employment at any time for any reason. In addition reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Required Experience:
Director
Employment Type
Full Time
