Regulatory Affairs Manager | Jenburkt Pharmaceuticals | Mumbai

Job Description

Role Responsibility:

1. Education and Expertise:

• A bachelor’s or Masters’s degree in pharmacy, pharmaceutical sciences, life sciences, or a related field is required.
• In-depth knowledge of pharmaceutical regulations and guidelines, including FDA regulations (or relevant regulatory authorities in other countries) and Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) standards.
• Familiarity with relevant regulatory frameworks such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

2. Regulatory Experience:

• Extensive experience in regulatory affairs within the pharmaceutical industry, preferably with a focus on drug development, submission, and approval processes.
• Proven track record of successful interactions with regulatory authorities, such as the National FDA, and other global regulatory bodies.
• Expertise in preparing and submitting regulatory filings, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and marketing authorization applications (MAAs).

3. Knowledge of Pharmaceutical Development:

• Strong understanding of the drug development process, from preclinical stages to clinical trials and post-marketing surveillance.
• Familiarity with the various phases of clinical trials and associated regulatory requirements, including protocol development, informed consent, data collection, safety reporting, and study documentation.

4. Communication and Leadership Skills:

• Excellent verbal and written communication skills, including the ability to communicate complex regulatory concepts effectively.
• Strong leadership abilities to manage a team and collaborate with cross-functional stakeholders, such as drug product development, manufacturing, quality control, and medical affairs.
• Demonstrated ability to provide strategic regulatory guidance and influence decision-making processes.

5. Ethical Conduct:

• A commitment to maintaining the highest ethical standards, ensuring compliance with regulations, and protecting patient safety.

Any past experience in Pharmaco Vigilance will be an added advantage.

Desired Candidate Profile:

Educational Qualification: M.Pharma

Experience: 12-15 Years