Regulatory Affairs jobs in United States

Please Note : Incumbent can be based anywhere in Europe or US

The Clinical Sciences / Clinical Development Director for dermatology shall be responsible for providing a high level of clinical expertise in Dermatology, from pre-registration to commercialization, to achieve Glenmark’s objectives across various markets. The individual will offer strategic and tactical clinical leadership for evaluating and planning clinical development programs, including protocol preparation, trial execution from a medical perspective, and regulatory interactions for registration trials and lifecycle management of innovative dermatology products. Additionally, the role involves reviewing scientific data and performing due diligence for in-licensing potential assets. The person will serve as a conduit between internal and external stakeholders throughout the development and lifecycle of products in various markets. The ideal candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets and familiarity with regulators such as the EU and USFDA.

Job Responsibilities :

1. Critically evaluate clinical data of investigational and similar drugs to inform clinical development strategies for registration purposes.
2. Collaborate with teams including Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Intellectual Property for planning, protocol development, execution support, and regulatory interactions.
3. Medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain partnerships with dermatology stakeholders, external experts, and health professionals to promote scientific understanding and advocacy.
5. Provide medical/scientific expertise to global medical affairs for due diligence in licensing and acquisition of new products.
6. Plan and oversee publication and presentation of data at international conferences, symposia, and journals.
7. Ensure all activities comply with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience :

1. MD or equivalent postgraduate medical degree in dermatology with approximately 10-12 years of experience in clinical sciences, regulatory studies, or Phase 1-3 clinical development in pharma/biotech companies. Understanding of drug development and regulatory pathways for dermatology products in various markets. Proficiency in evaluating, interpreting, and presenting complex clinical trial data. Ability to work across functions and in a matrix organization. Experience in financial/resource planning and management. Excellent communication and presentation skills, capable of addressing scientific and commercial needs. Skilled in coordinating with stakeholders across multiple geographies within and outside Glenmark.