MSD Hiring Regulatory Affairs Specialist - Candidates Apply Online

MSD Hiring Regulatory Affairs Specialist – Candidates Apply Online

Grab a great opportunity with MSD. Their Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. They are on the leading edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world.

Job Title: Regulatory Affairs Specialist

Location Vatika Towers, Gurgaon, India

Job Type Full Time

Eligibility Criteria: 

Education – Bachelor’s degree in Pharmaceutical Science

Working knowledge of Indian regulatory mechanism

  • Detail-oriented, meticulous and organized
  • Basic IT knowledge
  • Able to work within targeted timelines
  • Good project management skills
  • Self-motivated and strong commitment to achieving desired results and right first time
  • Team player

Responsibilities:

1. NEW PRODUCT REGISTRATION

  • Develops, drives, and finalizes new products approvals in India and for all products in neighboring markets, in line with local regulatory requirements and business plans.
  • Ensures submission in a timely manner and follows up to obtain earliest approvals for new products approvals in India and for neighboring markets.
  • During the assessment of the registration files, ensures adequate follow-up with regulatory agencies and addresses quickly agencies’ requests on quality clinical and non-clinical information.
  • Coordinates actions effectively and proactively with HQ and local support groups and in order to support product launches in due time and avoid business loss.

2. MAINTENANCE OF EXISTING PRODUCTS

  • Ensures timely submission and follow-up of both labeling and quality-related variations to the marketing authorizations, in cooperation with the key stakeholders: Ex., worldwide product labeling, CMC, RAI, HQ, and regional regulatory support team.
  • Ensures timely submission and follow-up of quality-related variations (CMC) to the marketing authorizations, in cooperation with the key stakeholders to the Health Agency laboratory.
  • Manages renewal process in liaison with CMC, RAI, HQ, and regional regulatory support team ensuring that renewal files are prepared, submitted, and approved in due time.
  • Efficient regulatory input for packaging and label components to ensure timely implementation of artwork efforts.

3. REGULATORY COMPLIANCE

  • Responsible for implementing local regulatory procedures in a timely manner, in close synergy with HQ /regional groups.
  • Trains appropriate personnel on regulatory procedures.
  • Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures

4. REGULATORY INTELLIGENCE

• Pro-actively shares intelligence on competitive products, generics, as well as on emerging regulations
• Responsible for supporting competitive intelligence

Apply Online

Editors Note: MSD Hiring Regulatory Affairs Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.

1 COMMENT

LEAVE A REPLY

Please enter your comment!
Please enter your name here