Assistant Manager/Manager-Regulatory Affairs

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.
 

• Education: Bachelor's Degree in Pharma or Science or similar and Master’s degree would be an added advantage.
• Work Experience: 8 to 10years of experience in Regulatory Affairs
• Required pre-requisites skills/experience for this position: Proficiency with MS Office suite.
   

• Strategy - Recognizes potential regulatory issues, solutions, and opportunities, identify the underlying processes and principles for developing product claims.
• Communication – Effectively uses technical and regulatory writing skills to author standard regulatory documents, reports, and public speaking

• Personal Effectiveness - Ensure personal compliance with relevant quality standards, evaluates the global healthcare environment and its potential impact on the organisation

• Technical – Ability to apply technical expertise in multi-disciplinary teams, explains key aspects of the healthcare product’s development process and identifies quality requirements for the development and post-market maintenance of healthcare products.

• Core Skills – Ability to develop standard operating procedures (SOPs) and policies and portraits leadership skills that inspire high performance within the regulatory environment.           
   

• Permissions and Procedures:

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.

• Quality Management: Perform quality and compliance specific tasks including but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination.

• Compliance for Galderma Global units: Meet and ensure necessary ethical, moral, and legal requirements in the areas of medico marketing, clinical trials, and CRM activities.

• Import - related activities: Facilitate the process of product imports by handling queries with related customs officials and analytical testing leading to the timely clearance of goods imported.

• Export - related activities: Compile, submit and coordinate for relevant data required for achieving company & product registrations in other countries in a timely manner like Sri Lanka/ Pakistan/ Bangladesh/ Nepal/ Maldives.

• Pharmacovigilance related Activities:

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.

• Local Product Development Projects: Participate in local product development projects which involve identification and validation of appropriate project, monitoring of contract research organization (CRO) involved in the project, involvement in the final stage of product development and liaising with Marketing, Manufacturing, CRO, Finance, Corporate and General Management.

• Packaging & Promotional Literature: Review all packaging artworks and promotional literature from a regulatory perspective as per internal and corporate SOPs in place for all products of Galderma India Pvt Ltd.

• Corporate & Legal Affairs: Liaison with corporate for trademarks and other related legal issues.

• Associations: Represent the company in the relevant committees of professional associations, e.g. OPPI – Medical Committee.

• ERT team members & OSHAS 18001

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.