Manager Regulatory Strategy

hace 1 mes

Barcelona, España Galderma A tiempo completo

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, 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’re 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.

Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma’s Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.

Job Title: Manager Regulatory Strategy

Location: Barcelona, Spain (Hybrid)

**Job Description**:
RA project team representative for assigned Rx product: for development projects and/or assigned registered Rx products

Advises/validates regulatory strategies, with the support of a Senior/Manager if needed, for these assigned projects and/or Rx products. Manages the registration of Rx products globally

Lifecycle activities of approved chemical drugs: maintenance of licenses, coordination with Pharmacovigilance for safety variations, marketing and medical for labelling changes and RA CMC for quality variations if applicable

Key Responsibilities

Development products:

- Maintains a global regulatory strategy plan; assures relevant input is vetted and included in the regulatory strategy in order to deliver on the Target Product Profile, regional specific needs, regulatory environment, regulatory risks and mitigations, and global submission strategies with the support of a Senior/Manager as applicable

New registrations
- Manages the new registrations of Rx products globally: defines the regulatory strategy, ensure strategic regulatory input is provided to release the core dossier and then work on all specific module 1 documents for each country - be the HA contact for US (if applicable) and for European procedures - dispatch the dossiers to other affiliates worlwide - identifies and assess risks associated and proposes mitigations plans accordingly in close collaboration with a Senior/Manager as needed

Maintenance
- Principal RA contact for assigned products globally and has an overview of all regulatory activities

Management:

- RA presentative for Project team / Global Regulatory Lead for assigned projects and/or Rx products

Quality:

- Ensures that all regulatory documents are prepared and tracked in EDMS and that all regulatory activities are tracked in the regulatory affairs database

Regulatory:

- Monitor internal and professional communications concerning relevant regulations (ICH, EMA,) in close collaboration with affiliates

Skills & Qualifications
- 5 years’ experience in Regulatory Affairs teams, development projects
- 3 years in an International Regulatory Affairs department.
- Experience with outsourcing Regulatory Dossier management
- Experienced with international project management
- Focused on effective delivery of objectives, even when working with tight deadlines
- 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
- Identify opportunities/major issues and to communicate impact
- Demonstrated ability to deal with rapid change

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

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