Life Science Parexel Vacancy – Regulatory Affairs Job Opening
Life Science Parexel Vacancy – Regulatory Affairs Job Opening. Life Science Jobs – Parexel Hiring, Apply Online. Parexel Regulatory Affairs careers. Parexel has job openings for life sciences candidates. Check out all of the details on the same below:
Parexel Vacancy Details
Designation: Senior Regulatory Affairs Associate
Requisition ID: 61300BR
Location: Bengaluru, Karnataka, India
- Good understanding of the regulatory framework, consisting of regional trends, for different types of applications as well as procedures for small as well as large molecules throughout all regions along with knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries. Experience with ROW countries would be a plus.
- Expertise in CTD/ eCTD compilation and also submissions, technical review of the submission documents along with Post Approval activities: Renewal, Variations and also various other lifecycle management activities (preferably for Europe, USA and also International markets would be an asset). Exhibit excellent CTD writing abilities.
- Comprehensive knowledge and also experience with developing regulatory CMC strategies and CMC dossier content requirements
- Products Portfolio includes Medicinal Products, Consumer Health, Biologicals, Vaccines etc.
- Lead as well as/ or add to the planning, preparation (including authoring where relevant) as well as delivery of simple, and also with experience, increasingly more complex regulatory upkeep submissions from either a global and/or regional perspective.
- Liaise carefully with cross-functional members with aligned product responsibilities.
- Develop, execute and also maintain submission delivery plans, submission content plans, and also proactively provide status updates to designated stakeholders.
- Identify regulatory risks as well as propose mitigations to Lead RPM as well as cross-functional teams.
- Support operational as well as compliance activities for assigned CMC deliverables, including generating work requests and submission content plans, submission tracking and also document management making use of the support and also the input of Global
- Regulatory Operations as well as Marketing Companies.
- Must able to prepare, review and also send Administrative, CMC related, Labelling along with Safety variations to Health Authorities as well as likewise perform post Approval related updates (where applicable).
- Ensure that the Regulatory Info Management system is maintained and updated for all activities under role responsibility, including review of documents.
- Well versed with MA Transfers as well as related activities ideally for EU and international markets.
- Strong knowledge and also experience of CMC gap assessment and also defining CMC action plans.
- Determine the types of regulatory submissions or internal documentation that are required in situations.
- Gap regulatory assessment (regulatory strategy) based upon relevant HA requirements.
- Preparing as well as Focusing on the gap resolution dossier concerning the update of the MA dossier as needed.
- Supports Site regulatory product managers with regard to Regulatory Gap assessments.
- Supports Site project teams as well as external stakeholders as part of project execution.
- Need to able to handle Health Authority Queries, Change Control management in addition to the coordination and also follow-ups with internal/ external stakeholders as well as local RA affiliates.
- Have to able to perform Artwork reviews.
- Aid and also provide support in the preparation, distribution as well as follow up of registration documentation needed to affiliates/ regulatory authorities.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Exhibits good project management abilities.
- Demonstrates capability to prioritize work and also define steps needed to achieve specified project outcomes.
- Ensure that quality standards are met and that the deliverables meet strict deadlines.
- Outstanding interpersonal as well as intercultural communication skills, both written and also verbal.
- Attention to details and also the capability to think strategically.
- Multi-tasking ability.
Qualifications: Any Life Sciences related discipline.
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