Director, Regulatory Strategy - Immunology

At Galderma we're unique and we embrace difference.

Whether it's the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our 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, non-clinical, 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 of INDs, 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 cross-functional 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 cross-training.

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, you'll 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.

Employer's 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.