Sanofi Pharma Regulatory Affairs Specialist – Candidates Apply Online
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Job Title: Specialist – Regulatory Affairs
Location: Hyderabad
Req Id: R2642896
Eligibility Criteria:
- Graduate/Post Graduate in Life sciences, Pharmacy.
- Minimum 6 – 10 years experience within Regulatory Affairs or in a similar function in the Vaccine or Biological industry with a good understanding of Industrial Operations experience is preferred.
- Demonstrated experiences in international and local regulatory affairs on Vaccines or Biological products.
- Previous Regulatory Affairs CMC authoring is a must.
Requirements of the job
- This position requires thorough knowledge on Vaccines or biotech/biological products manufacturing.
- This position requires a thorough understanding on the Indian Regulations and updating the regulations to cross-functional teams from time to time
- This position requires the incumbent to be proactive in meeting the organization’s needs.
- This position will suit an individual who is able to operate with discretion and confidentiality about sensitive data.
- To comply with HSE compliance and Business Ethics throughout the job
Other expectations
- Participates and Coordinates with cross-functional teams for gathering the required information /documents required for authoring the dossiers and query responses.
- Supports Site Regulatory Site Officer/Regulatory Product Manager with regard to Regulatory Gap assessments.
- Supports Site project teams and external stakeholders as part of project execution.
- Ensure close collaboration with Quality and Process Improvement teams to ensure optimal processes and tools are developed and implemented. Lead creation and revision of relevant SOP’s and work instructions. Evaluate and improve processes for submissions and regulatory information.
Duties & Responsibilities
- Act as a Team member and may need to play manager role in managing 1-2 people.
- Active participation in meeting the targets.
- To update the knowledge from time to time for effective delivery.
- Follow up with cross-functional teams, and ensure the target timelines are met.
- Handle requests, either internal or external, related to RA activities.
- Preparation and Submission of various applications, Responses, etc from to Indian Health authorities.
- Meeting with Regulatory authorities from time to time to fulfill the business needs.
Knowledge, Skills & Competencies / Language
- Team handling.
- Demonstrated capacity to take up additional tasks.
- Excellent communication and CTD writing skills.
- Knowledge of regulatory guidance.
- English proficiency, both oral and written.
- Multi-tasking ability.
- The candidate should have excellent interpersonal skills, be a self-driven proactive individual with skills in organization, building working relationships, and communication.
- Basic software knowledge (Microsoft windows etc.) is a must. Exposure to regulatory tools will be added advantage.
Regulatory Strategy, Authoring of dossiers and Preparation of query response, Database update, Working on RA e-tools
- Develop the regulatory strategy and keep the document updated throughout the Life cycle of the project/product to ensure coordination with the different areas concerned: Clinical Development, R&D, Marketing, and CMC-related functions.
- Authoring and reviewing of dossiers: Ensure that all data supplied to the affiliates/regulatory authorities are of the highest quality possible in terms of both content and presentation, whilst meeting agreed-on deadlines.
- Work proactively with members of the internal stakeholders to ensure project needs/transversal activities are met compliantly within agreed timelines.
- Assist and provide support in the preparation, distribution and follow-up of registration documentation required to affiliates/ regulatory authorities.
- Proper utilization of regulatory e-tools.
- Provide support transversely.
- Maintain and update all the relevant databases up-to-date.
- Review of artworks as per the labeling requirements.
Variations Management
- Regulatory Impact Assessment of Change controls (Variations).
- Preparation and review of documents required for Variation submission to Affiliates /Authorities.
- Tracking of all the changes and timely updates on the status on fulfillment of conditions mentioned in variation approvals.
Apply Online
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