MSN Laboratories Recruiting For Regulatory Affairs Manager Position. MSN Group is one of the fastest growing manufacturers of Active Pharmaceutical Ingredients (APIs) and Finished dosages in India. Established in the year 2003, MSN Group comprises of eight API manufacturing plants ( including one for Oncology), two finished dosage facility ( one more for Oncology being built) and a dedicated R&D Center and is growing 30-40% every year. Our plants are ISO 9001-2000 certified, WHO: GMP, EU:GMP and USFDA approved. Our manufacturing units are designed to confirm to the principles of Quality, Safety and sound Environment.
Eligibility and other details :
- Post Name:Regulatory Affairs Manager
- Qualification: B.Pharma,M.Pharma with 2-7 years hands-on experience
- Location: Hyderabad
- Salary:Not Disclosed
- No Vacancies: 01
- Selection Process : Based on Resume Received,will shortlist.
- The Regulatory Affairs personnel is responsible for task involving evaluating dossiers/queries and compilation of critical dossiers and queries, as and when required. This includes search/retrieval/editing of data logically for preparation of dossier/query.
- In order to collect/comprehend the various details as required for dossier evaluation/preparation, the Regulatory Affairs personnel is expected to visit various places like libraries and manufacturers plant of the Company, study country/ICH guidelines and guide the team members accordingly.
- The Regulatory Affairs personnel will be responsible for all activities carried out in the Department with respect to keeping the Department and systems in an order, assist in developing and implementing SOPs and maintain the electronic format of the work by maintaining the confidentiality.
- The Regulatory Affairs personnel is expected to attend technical conferences and other workshops as recommended by the Management.
- The Regulatory Affairs personnel will undertake effective correspondence/liaison with manufacturing plants for timely procuring the required data for dossier preparation.
- The Regulatory Affairs personnel will be responsible for registration of products in various countries abroad as per the registration guidelines.
- The Regulatory Affairs personnel will be responsible for maintaining high moral/discipline and secrecy of the Regulatory Affairs Department.
- The Regulatory Affairs personnel will be given a job other than above functions as and when required which is consistent with the job in Regulatory Affairs Dept. at the discretion of the Head of the Department / Management.