Female - Regulatory Affairs-Specialist (API Chemical Company)Sandhurst Road Mumbai 21

Double HR Consultancy

Urgent Opening

Regulatory Affairs-Specialist

(API Chemical Company)

Job LocationL : Sandhurst Road, -Head Office, Mumbai

• Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry

• Experience : Minimum 2-5 years of experience in regulatory affairs

• Salary : Good Hike on Current CTC

• Essential Duties and Responsibilities:

 Regulatory Compliance: Ensure company products comply with relevant regulatory requirements, such as USFDA, FDA, EMA, and local regulations.

 Submission Management: Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies.

 Regulatory Strategy: Develop and implement regulatory strategies to support product development and commercialization.

 Regulatory Intelligence: Stay up-to-date with changing regulatory requirements and provide guidance to internal stakeholders.

 Audits and Inspections: Coordinate and manage regulatory audits and inspections.

 Labeling and Advertising: Review and approve product labeling and advertising materials for regulatory compliance.

 Regulatory Agency Interactions: Communicate with regulatory agencies, such as the FDA, to address questions and concerns.

 Regulatory Documentation: Maintain and manage regulatory documents, such as regulatory submissions, approvals, and correspondence.

• Experience

  2 - 3 Years

• No. of Openings

  6

• Education

  B.Sc, M.Sc

• Role

  Regulatory Affairs Specialist

• Industry Type

  Chemicals / PetroChemical / Plastic / Rubber / Glass / Paints

• Gender

  Female

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office