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Regulatory Affairs Executive Pharmaceuticals

4 weeks ago

Haryana, India MEDYUR PHARMACEUTICALS LIMITED Full time

We are seeking a highly motivated and detail-oriented Regulatory Specialist to join our dynamic team within the pharmaceutical industry. This role is essential to ensure that our products comply with regulatory requirements and industry standards throughout their lifecycle. You will work closely with cross-functional teams including R&D, Quality Assurance, and Legal to drive the regulatory submission process, track regulatory changes, and maintain compliance with global regulations. Success in this role means providing timely, accurate, and effective regulatory support to enable the continued development and market access of our pharmaceutical products.

**Responsibilities**:

- Prepare, review, and submit regulatory documentation to appropriate regulatory agencies to obtain product approvals.
- Ensure compliance with current regulatory requirements by staying up to date on regulations, guidelines, and industry trends in global markets.
- Develop and maintain strong relationships with regulatory bodies to facilitate smooth communication and approvals.
- Review and assess changes to regulatory policies and recommend actions to ensure continued compliance.
- Conduct regulatory impact assessments to evaluate potential changes in regulations or market conditions that could affect product development or commercialization.
- Maintain regulatory files, records, and reports in accordance with internal and external requirements.
- Support regulatory inspections and audits by providing necessary documentation and expertise.

**Qualifications**:

- Bachelor’s degree in pharmacy, Life Sciences, Regulatory Affairs, or a related field. A master’s degree is a plus.
- Minimum of 2 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of global regulatory requirements and guidelines, including those from the FDA, EMA, ICH, and other regulatory agencies.
- Experience with regulatory submissions, including INDs, NDAs, ANDAs, and other relevant filings.
- Strong attention to detail with the ability to analyze and interpret complex regulations and scientific data.
- Excellent verbal and written communication skills, with the ability to effectively communicate complex regulatory issues to diverse audiences.
- Ability to work independently, prioritize tasks, and manage multiple projects under tight deadlines.
- Knowledge of pharmaceutical manufacturing processes, labeling requirements, and clinical trial regulations is a plus.
- Certification in Regulatory Affairs (RAC) is preferred but not required.

**What Success Looks Like**:

- Timely and successful submissions to regulatory agencies with mínimal need for resubmissions or delays.
- Strong collaboration with internal teams to ensure products meet regulatory standards at all stages of development.
- Continuous professional development to stay ahead of regulatory changes and trends.
- The ability to proactively identify potential regulatory risks and provide solutions to mitigate them.

Pay: ₹15,000.00 - ₹45,000.00 per month

Schedule:

- Day shift

Supplemental Pay:

- Commission pay

**Experience**:

- regul: 2 years (preferred)

Work Location: In person