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.
Responsible for ensuring that Galderma India is adhering to applicable regulations and help in developing strategies to ensure regulation compliance under the supervision of Lead – Medical & Regulatory Affairs.
A. DCGI (Delhi)
Liaison for approvals of relevant product marketing, registration certificates, import permissions. Liaison with concerned key officials & referred experts by regular interactions with local office and regular meetings with government officials. Ensure dossier compilation and submission of NDA via form 44 and registration certificate via form 40 including renewal agreement. Responsible for application of test license and import license along with necessary renewal processes if any. Coordinate with regulatory for clinical trials (if any), Protocol & CRF design, Liaison for protocol approval from DCGI and Ethics Committee, identify Investigators, initiate, and follow up for studies. Facilitate the process of analytical testing leading to the timely clearance of goods imported.
B. State FDA
Facilitate local manufacturers in obtaining manufacturing licenses and liaison with concerned key officials. Provide necessary clinical and technical documentation to local manufacturer. Effectively liaise between local manufacturer and corporate regulatory and MTO Departments. Facilitate design of draft labels.
Educate and implement concept of ADR reporting to field staff & doctors and report ADRs to Corporate. Act as deputy local safety officer who monitors phramacovigilance activities of the affiliates and its distributors.
Ensure safety training & mock drills are conducted in head office as per OSHAS guideline. Monitor safety equipment's status with respect to usage. Comply with OHSAS 18001 requirement within the department.