Sanofi Regulatory Affairs Job For BSc & MSc Life Sciences – Apply Online
Sanofi Regulatory Affairs Job For BSc & MSc Life Sciences – Apply Online. MSc, BSc job at Sanofi. Interested and eligible applicants can check out all of the details on the same below
Hey guys for those of you who are interested in applying for an Assistant Manager – Regulatory Affairs, Specialty Care job opportunity at Sanofi, then check out all of the possible interview questions listed below.
Job Title – Assistant Manager – Regulatory Affairs, Specialty Care
Job ID – R2709974
Location – Mumbai
Direction: GRA (Global Regulatory Affairs)
Report to: Regulatory Affairs Head – Vaccines & Specialty Care
Functional Reporting to: (when applicable) NA
Manager position: No
Mission statements:
The Regulatory Associate will report to the Business Unit Regulatory Affairs Head.
The Regulatory Associate will be responsible for managing products under development and/or marketed products.
Duties & Responsibilities:
Specific requirements and responsibilities include:
- Develop regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed products,
- Interface with various project/product teams.
- Coordinate dossier and briefing package preparations and submissions according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
- Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
- Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate..
- Manage the maintenance of a portfolio of products.
- Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of.
- Provide support and communicating information on products to other functions (approvals).
- Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies..
- In liaison with his/her manager, can be involved in activities such as shortages, DHPC, B/R reevaluation, review and approval of packaging material etc.
- Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
- Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
Key Individual Accountabilities:
- Plan for preparation / review of a new application submission corresponding to company plan as well as the agency guidelines for submission.
- Plan for preparation / review and submission of all the maintenance activities
- (Renewal & variations) based on company plans and the agency guidelines.
- Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
- Maintain the products labelling up to date , implementing global and local labelling decisions , through labelling preparation, review and approval
- Updating the internal Sanofi Systems regularly
- Carrying the planned LCM activities and reflecting the approvals on the internal systems
- Revision and approval of promotional Materials any updated packaging material on VISTA
- Preparation, submission and follow up of pricing files internally and externally.
- Assure compliance with IA files.
- Following and complying with all the defined internal policies and procedures of working.
- Following strictly all the Authority Regulations, decisions & decrees.
- Carry out all the required communication and follow up required with local affiliate, zone, region & corporate as appropriate.
Key Shared Accountabilities:
- Working closely with Pharmacovigilance & Medical to ensure timely submissions & follow up on products alerts & periodic reports
- Carrying the planned Activities in cross functional teams and reflecting the approvals on the internal systems
- Revision and approval of Promotional Materials and packaging material
- Work closely with the business teams for new product launches and maintenance of products
Knowledge, Skills & Competencies / Language:
- Negotiation & communication skills
- Organization skills and high accuracy in documentation
- High sense of urgency
- Knowledge of new decrees & guidelines
- Multitasker
- Awareness and adherence to company internal SOPs & compliance standards
- Promptness in respond to authorities requirements and prompt in deliverables
- Analytical skills
- Problem solving skills
- Presentation skills
- Interpersonal skills
- An understanding and appreciation of relevant legal, scientific and manufacturing area
- Language Requirements: Local Language and English, written and spoken.
Key Competencies:
- Act for Change*
- Strive for results
- Cooperate Transversally*
- Commit to Customer
- Think Strategically*
- Make Decision
* Prioritized competencies
Qualifications:
- Education: Physician, Pharmacist, Veterinarian or preferably Life Sciences Bachelor or Master Degree
- Related Experience: 3-4 years experience in similar position for different types of registrations, preferably in multinational organization
Requirements of the job:
- Knowledge of Drug and Cosmetics Act, Medical Device Regulations and New Drug Clinical Trial Rules (NDCT).
- Knowledge of rules for application to Ministry of Health.
- Masters degree is Preferred
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Here are five possible interview questions that could be asked in the technical round for the Assistant Manager – Regulatory Affairs position, along with their answers:
- Question: Can you explain the role of a Regulatory Associate in managing products under development and marketed products? Answer: The role of a Regulatory Associate involves developing regulatory strategies for products, coordinating dossier and briefing package preparations, ensuring compliance with Health Authority requirements, liaising with Health Authority contacts, managing a portfolio of products, reviewing promotional material, and providing regulatory expertise to other functions. It also includes responsibilities related to new applications, maintenance activities, labelling, pricing files, and adherence to internal policies and regulations.
- Question: How do you ensure compliance with regulatory guidelines while preparing and submitting applications for new registrations and variations? Answer: I ensure compliance by closely following the company’s plans and agency guidelines for submission, maintaining up-to-date product labelling through global and local decisions, updating internal systems regularly, implementing lifecycle management activities, and adhering to defined internal policies and procedures. I also maintain awareness of new decrees, guidelines, and regulatory changes to ensure our submissions are accurate and in accordance with regulations.
- Question: Can you describe a situation where you had to collaborate with cross-functional teams to achieve regulatory objectives? What was your role and the outcome? Answer: In a new product launch, I collaborated with Pharmacovigilance, Medical, and Business teams. My role included ensuring timely submissions, follow-up on product alerts and reports, reviewing and approving promotional materials and packaging, and reflecting approvals in internal systems. The outcome was a successful product launch with all regulatory requirements met, and a seamless communication and collaboration among teams to achieve our objectives.
- Question: How do you stay updated with changes in regulations and guidelines relevant to regulatory affairs in the pharmaceutical industry? Answer: I stay updated by regularly monitoring and following regulatory updates, decrees, and guidelines issued by relevant authorities. I also actively participate in industry seminars, workshops, and training sessions to enhance my knowledge. Additionally, I network with peers, attend webinars, and engage in discussions to stay informed about the latest changes and their potential impact on our daily activities.
- Question: Can you provide an example of a challenging regulatory situation you have encountered and how you successfully resolved it? Answer: One challenging situation involved a change in pricing regulations for a product. I had to prepare and submit updated pricing files internally and externally within a tight deadline. To resolve this, I coordinated closely with cross-functional teams, gathered required data, and ensured accurate submission. By maintaining effective communication and adhering to the regulatory timeline, we successfully updated the pricing files and remained compliant with the new regulations.
These questions aim to assess the candidate’s understanding of regulatory affairs, their ability to navigate complex regulatory requirements, their collaboration skills, and their proactive approach to staying informed about regulatory changes. The answers provided showcase the candidate’s expertise, problem-solving skills, and practical experiences in the field of regulatory affairs.
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