WhatsApp Group Join Now
Telegram Group Join Now

ad
AD

APN Biotech

5-10 years

Noida, Uttar Pradesh

B. Pharm / M. Pharm / M.Sc. degree

Verified Job

Email Application
Centered Ad Example

Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

APN Biotech Pvt Ltd, a fast-growing healthcare company based in Noida, Uttar Pradesh, is looking for an experienced Regulatory Affairs Specialist to join their dynamic team. If you have a background in pharmaceutical regulatory affairs and are looking to work with a company that has a strong global presence, this role could be the perfect fit for you.

About APN Biotech Pvt Ltd

APN Biotech Pvt Ltd is a rapidly expanding healthcare company that specializes in the manufacturing, marketing, and distribution of a wide range of healthcare products. The company has a strong presence in Southeast Asia, serving countries like Vietnam, Myanmar, Cambodia, and the Philippines. Their diverse product portfolio includes OTC medications, prescription drugs, food supplements, and herbal products, all aimed at addressing various health needs.

Role Description

As a Regulatory Affairs Specialist at APN Biotech Pvt Ltd, your primary responsibility will be to ensure that the company’s products meet all regulatory requirements. This includes preparing, submitting, and maintaining regulatory documentation for a variety of products across multiple markets. You will work closely with internal teams and manufacturing plants to ensure compliance and timely submission of dossiers to regulatory authorities.

Key Responsibilities:

  1. Regulatory Documentation: Prepare and submit regulatory documents, ensuring compliance with guidelines in different countries.
  2. Coordination with Manufacturing Teams: Work closely with manufacturing plants to collect required documentation (e.g., MFR, Specification, PVP, PVR, Stability Data) for regulatory submissions.
  3. Timely Responses: Address any queries raised by regulatory authorities in a prompt and efficient manner.
  4. Dossier Preparation: Be well-versed with CTD and ACTD formats and submit dossiers to regulatory bodies within required timelines.
  5. Team Management: Independently manage a team of regulatory professionals and ensure that submissions are completed on time.
  6. Global Regulatory Knowledge: Stay updated with the regulatory requirements of various countries, especially Southeast Asian markets like Vietnam, the Philippines, and others in the SEA region.

Qualifications

  • Educational Background: A B. Pharm / M. Pharm / M.Sc. degree.
  • Experience: 5-10 years of experience in regulatory affairs within an established pharmaceutical company.
  • Regulatory Knowledge: Familiarity with preparing dossiers for different countries and understanding of regulatory guidelines.
  • Dossier Formats: Well-versed with CTD and ACTD formats.
  • Experience with SEA Markets: Preference will be given to candidates who have experience submitting dossiers in countries like Vietnam, the Philippines, and the Southeast Asian region.
  • Communication Skills: Strong communication and coordination abilities.

Preferred Candidate Profile

  • Candidates who are based in Delhi-NCR or those who are willing to relocate to Noida will be given preference.
  • Experience managing a team of regulatory professionals and ensuring adherence to timelines is essential.

Salary and Benefits

  • CTC: The compensation for the role will be competitive and will not be a constraint for the right candidate.

How to Apply

Interested candidates can send their updated CV to Mr. Yogesh Rathore at dramanager@apnbiotech.in. Be sure to highlight your relevant experience in regulatory affairs and dossier submissions, especially in Southeast Asian markets.

ad
AD

Popup Ad Example
Sticky Buttons
Join WhatsApp Group References Join Telegram