RA Manager

Job Description:

 Position:         RA Manager

Location:         Ahmedabad

Experience:      10 - 12 Years

Industries:       Pharma

Responsibilities:        

• Review and comment on the deviation/change with respect to its impact on the regulatory status and aspects.

• To communicate with MOH and other Regulatory authorities regarding any notification, amendments, withdrawal for pre and post product approval.
• To ensure changes/deviations are complying to applicable.
• To ensure registered and approved methods, facility and controls are used for holding, manufacturing, testing, and packaging of the product of respective country.
• To Ensure required stability studies are conducted according to commitment submitted in the dossier.
• To review stability data in order to evaluate product shelf life / storage conditions and applicable labelling requirements.
• To ensure required studies are timely carried out for dossier submission.
• To ensure required samples are retained where applicable to support product registration / studies.
• To Participate in investigating issues related to quality complaints, adverse events during product lifecycle.
• Responsible for filling dossiers in prescribed formats of applicable countries. Responsible for risk assessment and reporting heavy metal impurities as per ICH Q3D for all materials and products.
•  To Review stability protocol and to ensure its compliance against requirements of intended market Responsible for identification of Reference Listed Drug Products, Reference Standards or products for BE Studies.
• To Communicate to Quality unit for upcoming regulatory requirement and expectation as applicable To review the requirement of artwork as per labelling guideline provided by various countries.
• Co-ordinate with F&D and business development in order to decide strategy for new product development Co-ordinate with F&D and business development in order to decide strategy for new product development Handling End to End Recruitment Process.  
• To Co-ordinate with various contracted agency for timely execution of activity as per SOP. To prepare and maintain record as per SOP.
• To impart the induction and orientation training to new joiners.
• To provide the safety and behavioral training as per schedule and as an when required.
• Candidate should have the knowledge of Row Market, & Foreign Market.

Required Skills:

• Must be excellent in written and spoken English; net savvy and adept at computer skills
• Attention for detail
• Team player
• Good in communication

Required Qualification: - B.Pharm/M.Pharm   

Salary: - Upto 12.00 LPA

If you are interested in this opening, please send updated resume on same mail with following details.

  Total No. of Years Experience: -

  Current CTC: -

  Expected CTC: -

  Notice Period: -