Regulatory Affairs - Pharma ( Formulations)

Job Description:

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.

They must have excellent organizational, analytical, project management, and communication skills.

They work frequently with other employees and team members to coordinate complex activities, often with competing priorities.

Most regulatory affairs positions are full time.        

                        
Regulatory Responsibility means a duty or responsibility, assigned to an individual by management.

                                                      
Candidate must have exposure of preparation of dossier, ECTD & ACTD etc. 

                                 
Regulatory compliance is when a business follows state, federal, and international laws and regulations relevant to its operations, Regulatory compliance involves following external legal mandates set forth by state, federal, or international government.     

                       
ensure that a company's products comply with the regulations of the regions where they want to distribute them.

keep up to date with national and international legislation, guidelines and customer practices.

collect, collate and evaluate scientific data from a range of sources.

develop and write clear arguments and explanations for new product licences and licence renewals.

prepare submissions of licence variations and renewals to strict deadlines.

monitor and set timelines for licence variations and renewal approvals.

work with specialist computer software and resources.

write clear, accessible product labels and patient information leaflets.   

                                            
liaise with, and make presentations to, regulatory authorities.

negotiate with regulatory authorities for marketing authorization.

Desired Profile / Criteria / Skills :

Minimum 2 years in regulatory affairs and should be well versed with Dossier making process as per individual country requirement (ROW market )