Unlock Healthcare Opportunities as a Regulatory Affairs Specialist

1 week ago

Hyderabad, Telangana, India beBeeregulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title:

Regulatory Affairs Specialist

We are seeking an experienced Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals in Europe.

This role is pivotal in managing activities pertaining to new application submissions for Europe through DCP, MRP, NP.

Key Responsibilities:

  1. Preparation, review and submission of new applications through DCP, MRP, NP for EU.
  2. Responsibility for preparation and review of m1 documentation in-line to the m2-5 documents.
  3. Product information preparation and artwork review for regulatory compliance.
  4. Direct interaction with EU regulatory authorities.
  5. Handling deficiencies and timely response to regulatory agencies.
  6. Effective communication with cross-functional teams and stakeholders.
  7. Participation in industry association meetings to stay updated on regulations.
  8. Creation and revision of SOPs (Standard Operating Procedures).

Requirements:

  • M.Sc or M.Pharm degree.
  • Minimum 8-12 years of experience in regulatory affairs, preferably in Europe registrations.
  • Knowledge of EMA guidelines.
  • Excellent spoken and written English proficiency.
  • Proficiency in using a computer and its applications, specifically Google Applications and MS Excel.
  • Strong interpersonal and communication skills.

About Us:

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide.

We have end-to-end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs.

Our portfolio includes over 1,000 products, driven by a robust R&D team consisting of more than 200 scientists and functional experts.

Benefits:

  • Personalized learning programs for career growth and professional development.
  • Competitive benefits package, including medical coverage for yourself and your family, life coverage for yourself.

Work Culture:

We foster a culture of empathy and dynamism, where people with diverse skills come together to achieve a common purpose.

When individuals with shared values work together, they can create magic.

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