Regulatory Affairs Specialist

2 weeks ago

Hyderabad, India Makro Full time
Job Title: Regulatory AffairsSpecialistCompany:MakroCareLocation:Hyderabad Telangana(Onsite)
CompanyDescription:MakroCare is aleading provider of regulatory and clinical development solutionsbased in Hyderabad Telangana. We specialize in offeringcomprehensive services in clinical research regulatory submissionsand scientific communication. Our team is dedicated to deliveringhighquality innovative solutions to support our clients in thepharmaceutical biotechnology and medical deviceindustries.
PositionOverview:As a RegulatoryAffairs Specialist at MakroCare you will be responsible formanaging and overseeing regulatory submissions and communicationswith drug regulatory authorities. This includes ensuring compliancewith CMC eCTD/CTD requirements and staying abreast of regulatorychanges in the US UK EU and ROW (Rest of the World) markets. Theideal candidate will have a strong background in regulatorypublishing and submission processes and will play a crucial role inmaintaining the high standards of MakroCares regulatoryoperations.
KeyResponsibilities:
  • RegulatorySubmissions:
  • Prepare and reviewregulatory submissions in compliance with CMC eCTD/CTDrequirements.
  • Ensure timely and accuratesubmissions to regulatory authorities in the US UK EU and ROWmarkets.
  • RegulatoryCompliance:
  • Monitor andinterpret regulatory requirements andguidelines.
  • Ensure compliance with all relevantregulatory standards andpolicies.
  • Publishing andSubmission:
  • Expertly handle thepublishing and submission of regulatorydocuments.
  • Manage and maintain submissiontracking systems.
  • RegulatoryStrategy:
  • Develop and implementregulatory strategies to ensure successful registration andmaintenance of products.
  • Liaise with regulatoryauthorities and provide strategic guidance on regulatorymatters.
  • CrossfunctionalCollaboration:
  • Work closely withcrossfunctional teams including R&D Quality Assurance andClinical Development.
  • Provide regulatorysupport and guidance throughout the productlifecycle.
  • Documentation andRecord Keeping:
  • Maintainaccurate and uptodate regulatory documentation andrecords.
  • Prepare reports and documentation forinternal and externalaudits.

EligibilityCriteria:
  • Education:
  • Bachelorsor Master s degree in Life Sciences B Pharmacy or MPharmacy.
  • Experience:
  • 48years of experience in Regulatory Affairs specifically within theHealthcare Clinical Research Biotech Biopharma or Medical Deviceindustries.
  • Extensive experience with CMCeCTD/CTD requirements.
  • Proven expertise inregulatory publishing and submissionprocesses.
  • Strong understanding of regulatoryrequirements in the US UK EU and ROWmarkets.

Skillsand Abilities:
  • Stronganalytical and problemsolving skills.
  • Excellentwritten and oral communicationskills.
  • Detailoriented with a strong focus oncompliance and quality.
  • Ability to managemultiple projects and deadlines.
  • Proficiency inregulatory submission software andtools.

MakroCareis an equal opportunity employer. We celebrate diversity and arecommitted to creating an inclusive environment for allemployees.

cmc,regulatoryaffairs,clinical development,publishing,regulatorysubmissions,documentation,row,compliance,clinicalresearch

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