Regulatory Affairs Team Lead (Sanofi Pasteur, Diabetes & Sudan)
Sanofi -
Cairo, EgyptPosted 5 years ago55People have clicked1 open position
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Job Description
- Accountable for the management of Regulatory Associates team in charge of development/maintenance projects
- Responsible for managing the regulatory strategy, the on-time delivery of compliant major submissions to Regulatory Agencies and for the delivery of responses to Regulatory Agencies questions
- Responsible to know, to adhere to and to advise others on Regulatory Authority regulations and guidance
- Ensure compliance of all regulatory activities with all applicable laws, regulations, Regulatory Authorities requirements and company procedures
- Provide guidance to various teams and stakeholders across the company organization on regulatory requirements/policies for development and marketed products
- Participate in discussions/meetings with Regulatory Authorities as required
- Participate in other projects and activities, such as leading implementation of changes to processes,
- 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 (submissions, approvals ..,…etc)
- Liaise with HA contact person; organizing and preparing HA meeting and leading.
- Manage activities such as shortages, DHPC, B/R reevaluation, etc.
- Follow regulatory changes, market changes and assess potential impact on daily activities and project strategy.
- Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies.
- Work in compliance with Sanofi Quality Documents (QDs).
- Train/coach Regulatory Associates in his/her team.
- Develop good relationship with third parties, agents providing regulatory guidance and leadership for in/out license compounds & acquisitions (if applicable).
- Accountable for timely Batch release for vaccines & related activities.
Others:
- Perform other duties as assigned.
- Respect of company’s values, code of ethics and social charter.
- Respect of personal data protection charter.
- Responsible for applying the HSE related requirements for the company in all related working procedures
Job Requirements
Key “Must Have” competencies, skills & experiences
- Education: Pharmacist, Physician, Veterinarian.
- Related Experience: Minimum 5 years of experiences in Regulatory Affairs
- Demonstrated ability to independently lead submission teams and implement regulatory strategies.
- Excellent understanding of the pharmaceutical industry, drug development environment, and company processes and objectives
- Expert knowledge of country regulations and requirements
- Ability to evaluate the impact of the regulations on drug development and the regulatory maintenance of Marketing Authorizations, and to propose solutions integrating the mid/long term business strategy
- Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor
- Strong interpersonal skills to motivate his/her team and liaise effectively with internal and external contacts
- Ability to interact and communicate effectively and efficiently with other functional departments in the business and with Health Authorities,
- 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.
- Ability to quickly gain required therapeutic / product knowledge
- Ability to work with multi functional and multicultural teams
- Awareness and adherence to company internal SOPs & compliance standards
- Promptness in respond to authorities requirements and prompt in deliverables.
- Analytical & Problem solving skills
- Fluent English Language
Desirable “compromise” skills
- 2 years of regulatory experience handling biological products.
- Comprehensive knowledge and operational expertise of the international regulations
- An understanding of relevant legal, scientific and manufacturing area
- Project management experience in regulatory environment
- People management
- Ability to act as a Business Partner
LEAD competencies:
- Act for Change, Strive for results, Cooperate Transversally, Commit to Customer
- Think Strategically, Lead Teams, Develop People, Make Decisions
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