Regulatory Affairs Manager
3 weeks ago
TheManager of regulatory and Strategic Development will be responsiblefor developing and implementing and regulatory strategies forclient projectsThe incumbent will beresponsible for the strategy and preparation of regulatory andlabelingrelated projects for the US FDA EU and ROW regulatoryauthorities.The position will include clientand regulatory authority liaison. The position will include thesupervision and management of regulatory professionals and supportpersonnel.
JobDuties andResponsibilities:
- PreparationReview and submission of Technical documents/Dossiers (CTD/ACTD)for Regulatory and Non Regulatory Markets Publishing electronicregulatory submissions (eCTD).
- Submission buildactivities creating interdocument links performing quality checksand validating compiled submissions and finalizing submission byrequired dispatch date.
- Coordinate &engage with RA Ops team for timely submissions / Publishingtasks.
- Reviewing manufacturing documents likeMFC BMR process validation Protocol/report stabilityprotocol/report sampling protocol process validation protocol andPDR.
- Create monitor and maintain timelines forclient strategic development submission management and regulatoryaffairs programs.
- Develop and execute on globalstrategic plans (regulatory and/or quality systems) for thedevelopment of client medical device development programs Act assubject matter expert in certain areas of EU MDR /IVDR
- Establish and direct crossfunctional teamsof internal and external personnel to deliver clientprojects.
- Support Regulatory Operations /Submission management Automation / ITefforts
- Provide training for inhouse personneland supervise the assigned Regulatory staff asneeded.
- Participate in meetings with regulatoryauthorities
- Monitors activities of applicableregulatory agencies and industry organizations to identify anychanges in regulations and communicate to appropriatepersonnel.
- Shows an understanding of thechanging regulatory environment and the impact on businesspractices policies and projects and demonstrates an ability todiscuss relevant points in a diverse forum in more generalterms.
SupervisoryResponsibilities:
- Directlysupervises employees assigned. Carries out supervisoryresponsibilities by the organizations policies and applicablelaws.
- Responsibilities include interviewinghiring and training employees; planning assigning and directingwork; appraising performance; rewarding and disciplining employees;addressing complaints and resolvingproblems.
- Manages applicable portions ofestablished departmental budget using good judgment to ensure thatcosts are appropriate and reasonable and that any foreseen overagesare communicated fortransparency.
Qualifications:
- AnyBachelor/Master in Any Life Science with a Minimum712 years of experience within CRO /Biotech / Biopharma industry.
- Gap AnalysisHandson experience in publishing and Knowledge on CTDcompilation
- The ability to deal effectivelywith sponsors and internal customers at alllevels.
- Excellent communication andinterpersonal skills both written andspoken.
Role: Regulatory AffairsManagerIndustry Type: Clinical Research / ContractResearchDepartment: RegulatoryAffairsEmployment Type: Full TimePermanent
Education UG: AnyGraduatePG: Any Postgraduate MBA/PGDM in AnySpecializationDoctorate: Doctorate NotRequired
regulatoryaffairs,publishing,electronic common technical document(ectd),regulatory submissions
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