Job Description
▪ Develop and execute regulatory strategies and plans to ensure compliance with applicable laws,
regulations, and standards.
▪ Stay updated on changes in regulatory requirements and translate them into actionable steps for
the organization.
▪ Collaborate with cross-functional teams including R&D, Production, QA, Packaging, designing, PM
etc. to ensure that all regulatory requirements are met throughout the product lifecycle.
▪ Prepare and submit regulatory submissions, including but not limited to, product registrations,
pre-market notifications, and post-market surveillance reports.
▪ Liaise with regulatory authorities and act as the primary point of contact during inspections, audits,
and regulatory agency interactions.
▪ Conduct risk assessments and develop mitigation strategies to manage regulatory risks.
▪ Review and approve product labelling (artworks), promotional materials, and other relevant
documentation to ensure compliance with regulatory requirements.
▪ Provide regulatory guidance and offer support to internal stakeholders, including product
development teams, to ensure that regulatory requirements are incorporated into the
development process.
▪ Monitor and track regulatory compliance metrics and provide regular reports to senior
management.
▪ Maintain a thorough understanding of international regulations in targeting markets and guide the
organization regarding international regulatory fulfilment plans against the regulations.
Qualifications required:
▪ Degree in Pharmacy, Life Sciences, Biological Sciences, or a related field.
▪ 5 - 7 years of experience in regulatory affairs in the pharmaceutical industry (experience with
nutrition is a plus).
▪ Proven experience in planning regulatory strategies and getting product approvals.
▪ Good knowledge of regulatory filing in India and international markets (US, EU, and Rest of the
World).
▪ Experience working with regulatory authorities and handling inspections/audits.
▪ Strong understanding of quality systems.
▪ Experience in preparing and maintaining regulatory documents such as technical files and dossiers.
▪ Ability to collect and organize data required for product registrations and ensure compliance with
regulatory requirements.
▪ Strong communication skills with fluency in English.
▪ Good analytical, interpersonal, and negotiation skills.
▪ Able to meet deadlines consistently.
▪ Capable of prioritizing, multitasking, and working both independently and in a teamLocation
Hyderabad, Hyderabad, Telangana, India 500006Qualification
Degree in Pharmacy, Life Sciences, Biological Sciences, or a related field.