Regulatory Affairs Manager

13 hours ago

India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full time

About Medisal Pharma


As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a significant impact on healthcare in India . To support our expanding operations, we are looking to hire a skilled Regulatory Affairs Manager to oversee our regulatory affairs and ensure compliance in India .


Why Join Medisal Pharma


  • Innovative Environment : Work in a dynamic organization that fosters creativity and embraces new ideas to advance healthcare solutions.
  • Career Growth : Take advantage of professional development opportunities and grow within an internationally recognized company.
  • Global Impact : Engage in meaningful projects that positively affect healthcare outcomes locally and globally.
  • Collaborative Culture : Join a supportive team that values diversity, teamwork, and mutual respect.


Job Summary


We are seeking an experienced and highly motivated Regulatory Affairs Manager to join our team in India . The successful candidate will play a key role in ensuring that Medisal Pharma's products comply with all regulatory requirements in India while supporting our operational growth. This role involves developing regulatory strategies, managing submissions, ensuring compliance, and collaborating with cross-functional teams to drive product success in the Indian market.


Key Responsibilities


Regulatory Strategy and Planning

  • Develop and implement effective regulatory strategies to expedite product approvals and market launches in India.
  • Provide regulatory guidance during product development to ensure compliance and optimize timelines.


Regulatory Submissions and Approvals

  • Prepare, compile, and submit high-quality regulatory dossiers for product registrations, renewals, and variations to CDSCO .
  • Manage responses to regulatory inquiries and deficiencies promptly to facilitate approvals.


Compliance Monitoring

  • Stay updated on changes in Indian pharmaceutical regulations, guidelines, and standards.
  • Assess and address the impact of regulatory changes on company processes and products.


Cross-Functional Collaboration

  • Work closely with R&D, Quality Assurance, Manufacturing, Supply Chain, and Marketing teams to gather documentation and ensure regulatory compliance.
  • Participate in project teams to provide regulatory input and support decision-making processes.


Regulatory Intelligence and Advocacy

  • Engage with industry associations and regulatory agencies to influence policy development and remain informed of industry trends.
  • Represent Medisal Pharma at regulatory meetings, workshops, and conferences.


Documentation and Record Management

  • Maintain organized and comprehensive regulatory files and databases.
  • Ensure regulatory documents are accurate, up-to-date, and accessible for audits and inspections.


Training and Development

  • Mentor and train junior regulatory staff on best practices and regulatory requirements.
  • Foster a culture of compliance and continuous improvement across teams.


Risk Management

  • Identify potential regulatory risks and propose mitigation strategies.
  • Conduct internal audits to ensure adherence to company policies and regulatory standards.


Qualifications


Education

  • Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related field.
  • A Master’s degree or certification in Regulatory Affairs is highly preferred.


Experience

  • Minimum of 5 years of progressive experience in regulatory affairs within the Indian pharmaceutical industry.
  • Proven track record of successful product registrations and regulatory project management with CDSCO .


Knowledge and Skills

  • Strong understanding of Indian pharmaceutical regulations, including the Drugs and Cosmetics Act and WHO-GMP guidelines.
  • Proficiency in electronic submission platforms and regulatory information management systems.
  • Excellent analytical, organizational, and project management skills.
  • Strong communication skills, both written and verbal.


Personal Attributes

  • High level of integrity, professionalism, and ethical judgment.
  • Detail-oriented with the ability to prioritize and meet deadlines.
  • Adaptable and capable of performing under pressure in a dynamic environment.


What We Offer


Competitive Compensation Package

  • Attractive salary based on qualifications and experience.
  • Annual performance bonuses and incentives.


Comprehensive Benefits

  • Health insurance and wellness programs.
  • Paid time off, including vacation and sick leave.


Professional Growth Opportunities

  • Support for certifications, continuing education, and professional memberships.
  • Access to industry events, seminars, and networking opportunities.


Inclusive and Collaborative Work Environment

  • Commitment to diversity, equity, and inclusion in the workplace.
  • Regular team-building activities and company-sponsored events.


How to Apply


If you are ready to advance your career and contribute to Medisal Pharma's mission of improving healthcare in India, we invite you to apply.


Please send your updated resume and a compelling cover letter detailing your relevant experience to . Use the subject line: Application for Regulatory Affairs Manager – India (Your Full Name) .


Join Our Mission at Medisal Pharma


Embark on a rewarding career where your expertise in regulatory affairs will have a tangible impact on healthcare in India. At Medisal Pharma, we value the contributions of our team members and are committed to fostering a culture of growth, innovation, and excellence.


For more information about Medisal Pharma, visit our website at .

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