Director, Regulatory Strategy - Immunology

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing 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 body's 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, 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 & i