Job title: Head Regulatory Affairs – Vaccines & Genzyme
Company: Sanofi
Job description: Purpose
The role has overall responsibility for all Specialty and Vaccines product related activities in Regulatory Affairs including interactions with regulatory authorities, government bodies and interactions with the regulatory area and other internal/external stakeholders
Duties & Responsibilities
Regulatory Leadership in VACCINES & SPECIALTY CARE for India Nepal Sri Lanka and Maldives
Manage the RA function and define local RA priorities
Contribute to RA strategies by providing proactive RA support taking into account local RA requirements and local business needs.
Ensure advice and regulatory input is provided to local business strategies with regards to regulatory feasibility, requirements and timelines.
Be responsible for regulatory risk assessment and management
Ensure submissions of new chemical entity / new generic product / line extension / new indication /food supplement / Cosmetics / medical device /Biosimilars according to planned submission dates.
Manage the local RA budget in collaboration with the Finance Department.
Maintain optimal resource capacity for performing required regulatory activities.
Ensure high quality submissions within timelines agreed with GRA, business and/or health authorities
Take active part as member leadership team.
Lead, motivate and develop the local RA team, and ensure the RA team members maintain and develop their regulatory skills and keep up-to date with the national and international regulatory environment by appropriate trainings.
Regulatory Compliance
Ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses.
Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national and local regulations.
Actively follow the development and emergence of new regulatory requirements and assess their impact on the existing products and in development.
Review and approve promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Co-ordinate review with the responsible functions in the country.
Ensure timely and accurate completion of databases (VAULT, STARR etc.).
Health Authority Interactions:
Act as the primary interface between the company and local regulatory authorities. Build good relationship, making Sanofi a recognized partner with the agencies. Ensure Sanofi RA active participation in local trade associations to influence the regulatory environment in accordance with company strategy, and closely monitor changes in the regulatory environment and provide input on draft guidelines.
Drug Development
Give Input to GRA for drug development with regards to local regulation
Support the local CSU organization in approval procedures for clinical trials if needed.
Risk Management
Co-ordinate the local health authority approval of risk management plans, DHPCs and educational material.
Ensure public availability of current approved product information for risk minimization (Sm PC, educational material, PIL)
Be responsible for regulatory risk assessment and management
Portfolio rationalization: Provide RA input to product portfolio optimization and product pruning at affiliate level and give RA input to global product portfolio optimization strategies.
Coordinates the on time dispatch of the required documents and submission files by ensuring communication with Corporate and related departments
Ensures the preparation of the submission files accurately according to local law and regulations.
Negotiates with MoH and commission members before the submission, if necessary.
Approves the relevant documents in the submission file and cover letter.
Set up objectives of RA team based on GRA and business priorities
Ensure achieving launches in the planned time in regulatory perspective
Anticipate and provide impacts on our current and future products in view of the new legislations & regulations and preparing proactive strategic decisions accordingly
Coordinate with other departments in team work to achieve objectives
Transversal working
Supply Chain/ Quality :
Give regulatory green light in case of GMID code switch
Ensure Regulatory input is given to optimize product launch
Give regulatory input to support market access activities per local regulation if applicable
Lead the discontinuation process
Medical : validation of advertising support, for file preparation, validation of summary of the dossiers if applicable:
Regulatory assistance for other department
Give regulatory input to release batches as required
Knowledge, Skills & Competencies
Good knowledge in South Asia and EU/US regulatory legislation, procedures and guidelines governing pharmaceutical, biological products and medical devices
Ability to plan projects and understand priorities
Knowledge about how to track business priorities
Knowledge and application of due diligence regarding in and out licensing
Analytical and organizational skills
People and project management skills
Verbal and written negotiation and interpersonal communication skills
Ability to work in multicultural environment
Ability to demonstrate diplomacy and assertive skills in dealing with internal and external partners
Strong interpersonal skills to motivate the team and liaise effectively with internal and external contacts
Good skills in communication and teamwork
Ability to communicate effectively and efficiently with other functional departments in the business
Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities and prioritize the regulatory activities
Qualifications
Education : Physician, Pharmacist, Veterinarian or Life Sciences Graduate / Post Graduate .
Related Experience: At least 7-10 years regulatory experience in similar position in a Pharmaceutical Company, preferably international.
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.
Expected salary:
Location: Mumbai, Maharashtra
Job date: Wed, 08 Jun 2022 22:39:57 GMT
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