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.