Regulatory Affairs Specialist - ROW, EU

Job Description Regulatory Affairs

Organization : Orbicular Pharmaceutical Technologies Pvt Ltd

Industry : Pharmaceutical - Formulation Research & Development

Work Location : ALEAP, Pragathinagar, Hyderabad.

Qualification : M.Sc / M.Pharm

Experience : 5 9 Years

Position : Executive/Sr.Executive/AM

Department : Regulatory Affairs

Desired candidate field : Regulatory Affairs knowledge with formulation injectable experience in Europe & ROW market.

Company Overview:

Orbicular Pharmaceutical Technologies Pvt. Ltd. is a research-driven company specializing in the development of niche generic and specialty pharmaceutical products. Our CI-TOP SPIN strategy focuses on Complex Injectables, Topicals, Ophthalmic, Parenteral, Nasal Sprays, and Inhalations, targeting complex and profitable domains. With expertise in formulation and drug delivery technologies, we offer a diverse range of solutions across therapeutic areas and dosage forms. Partnering with national and international drug manufacturers and backed by a team of experienced techno-entrepreneurs and renowned scientists, we have a strong track record of delivering innovative products from concept to commercialization.

Key Responsibilities:

• Under the guidance of the Team Leader, you should be able to submit the product registration dossier of assigned products to targeted countries in the Europe & ROW as per requirements.
• File all the required variations and renewals of assigned products in line with guidelines and checklists as per the plan.
• Respond to queries received from regulatory agencies, business units, or other stakeholders, ensuring complete and accurate information is provided within predefined timelines.
• Maintain various regulatory databases in a timely manner.
• Keep yourself updated with the relevant current EMEA, and ICH guidelines and requirements.
• Ensure support in the execution of any projects assigned as per business needs.
• Be well-versed and possess sound regulatory knowledge on complex injectable formulations (e.g., Peptides, Iron colloidal molecules) and drug-device combination products.(preferrable)

Skills and Competencies:

• Prior registration experience mainly in EU markets, Brazil, Canada, Australia & ROW.
• Ability to handle projects (initial submission, query response, post-approval) independently.
• Should have excellent communication skills.
• Well-versed in relevant guidelines, including ICH.
• Proficiency in using Excel, PowerPoint, and other relevant software.
• Readiness to take on challenges and relocate for work as required.
• Ability to coordinate intra- and inter-departmental activities and across global sites.
• Strong document review skills and good technical knowledge.
• Ability to multi-task efficiently.

The above-mentioned JD and responsibilities include, but are not limited to, the job.