Job Openings
Regulatory Affairs Manager - ADC
About the job Regulatory Affairs Manager - ADC
Job Title: Regulatory Affairs Manager - ADC
Job Location: Mumbai, Maharashtra, India
Job Location Type: On-site
Job Contract Type: Full-time
Job Seniority Level: Associate
MAIN PURPOSE OF ROLE
Experienced professional individual contributor that works under limited supervision.
Applies subject matter knowledge in the area of Regulatory Affairs.
Requires capacity to apply skills/knowledge within the context of specific needs or requirements.
Main Responsibilities
Education
Associates Degree (± 13 years)
Experienced professional individual contributor that works under limited supervision.
Applies subject matter knowledge in the area of Regulatory Affairs.
Requires capacity to apply skills/knowledge within the context of specific needs or requirements.
Main Responsibilities
- As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- Interacts with regulatory agency to expedite approval of pending registration.
- Serves as regulatory liaison throughout product lifecycle.
- Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
- Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
- Serves as regulatory representative to marketing, research teams and regulatory agencies.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Education
Associates Degree (± 13 years)
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please use the below Lifelancer link to Apply and view similar roles.
https://lifelancer.com/jobs/view/50b2ba4e2c32e4dc859179dc9d1925b2