Regulatory Affairs Specialist At Orchidia Pharmaceutical
Job Description
Purpose of the job:
Responsible for filing necessary applications, all activities relating registration requirements and line extension indications, regulatory approvals, maintaining of the products registration, and handling all government interactions pertaining to the regulation process for current & future products/lines.
Primary Tasks:
Responsible for Pharmaceutical products, Dietary supplement, Medical Devices and cosmetics products in the following areas.
Oversee the regulation process for products requiring governmental or international approvals.
Update licensing and collects information on registration instructions and regulations.
Obtain/generate information to be submitted to regulatory authorities and prepares required regulatory dossiers.
Manage the final product submissions and negotiates and communicates effectively with regulatory authorities to obtain timely product approvals & pricing.
Provide direct assistance with the registration of new and existing products in markets supplied by the plant.
Assume regulatory review of labeling content, product and process changes and product documentation.
Manage the distribution of new regulations, standards, policies, and guidelines issued by relevant regulatory authorities that may impact the company.
Archive all related work documents soft and hard copies.
Submit and follow up new registration, Re-registration, variation files for analysis till receiving conformity.
Follow up batches and raw material samples submitted for analysis till receiving conformity.
Maintains a high level of knowledge and skill on current matters concerned with the regulation and approval of medicinal products and devices.
Undertaking and managing regulatory inspections.
Perform any assigned duties related to DRA.
Education, Skills, Experience required:
Bachelor’s degree in pharmaceutical science or science.
From 1 to 3 years of experience in pharmaceutical industry. Extensive knowledge of regulatory applications and procedures.
Experience of Drafting Regulatory Files.
Excellent English, verbal / written communication.
Strong communication skills and networking.
Ability to work well through others.
Excellent computer skills.