Regulatory Affairs Manager

3 days ago

Delhi, 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 PlanningDevelop 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 ApprovalsPrepare, 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 MonitoringStay 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 CollaborationWork 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 AdvocacyEngage 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 ManagementMaintain organized and comprehensive regulatory files and databases.Ensure regulatory documents are accurate, up-to-date, and accessible for audits and inspections.

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

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

Qualifications

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

ExperienceMinimum 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 SkillsStrong 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 AttributesHigh 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 PackageAttractive salary based on qualifications and experience.Annual performance bonuses and incentives.

Comprehensive BenefitsHealth insurance and wellness programs.Paid time off, including vacation and sick leave.

Professional Growth OpportunitiesSupport for certifications, continuing education, and professional memberships.Access to industry events, seminars, and networking opportunities.

Inclusive and Collaborative Work EnvironmentCommitment 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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