The RA Country Lead Israel is responsible for the preparation and execution of optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the regional business.
Provide effective liaison with the Israel regulatory authorities through Shire Pharmaceutical Israel Ltd or distributor contacts, ensuring escalation of key issues where required. Help to maintain and further develop Shire’s reputation with the Israel Ministry of Health
Fullfill the obligations of the Appointed Pharmacist under the Israeli Drug Law.
Develop effective relationships with local commercial organisation and distributors in Israel.
Provide Global GRA functions with regulatory guidance and advice on the local country regulatory environment.
Provide assessment of the impact of new and changing regulations/requirements in Israel.
Use external resources to assist with the above tasks to not only meet timelines but expedite approvals and time to market.
Job Function and Description
- In collaboration with International RA Strategists, provide regulatory strategies to responsible functional groups and regulatory management.
- Prepare and submit investigational applications, market applications, variations, renewals, dossiers supporting post approval reporting obligations and provide general product life cycle management support for Israel
- Prepare and maintain project plans and target timelines of approvals and planned submissions.
- Prepare and review key application components and meeting materials, chair/attend meetings with regulatory agencies and participate in agency inspections as required.
- Provide guidance/advice on national regulatory environments and assess the potenial impact of new and changing regulations/requirements
- Develop effective working relationships with business partners based in Israel, including visits as needed.
- Ensure appropriate evaluation of local business and product registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed.
- Interact with distributors and regulatory agencies to resolve questions.
- For assigned projects, act as a point of contact and as interface with key corporate functional areas
- Ensure compliance of regulatory activities in Israel with Country laws and Shire internal protocols and procedures (CMLR, Labelling compliance, etc.) in coordination and liaison with GRA labelling and Ad/Prom
- Develop relevant regulatory department local operating procedures (CMLR, etc.)
- Ensure that local regulatory documentation is archived in a secure and comprehensive manner
- Ensure that all local product information used locally are up to date
- Provide guidance/advice on international regulatory developments, provide assessment of the impact of new and changing regulations/requirements .
- Develop effective working relationships with business partners in Israel, including local visits as needed.
- Support the Head RA EAMEA and International RA team on specific projects as requested.
Education and Experience Requirements
- University degree in Pharmacy
- 15+ years experience working in drug regulatory affairs as a Responsible Pharmacist
- Accredited by Israel MOH as ‘Appointed Pharmacist’
- Interpersonal skills and professional skills to interact with subcontractors while representing Shire
- Experience with working directly with subcontractors to resolve compliance deficiencies
- Excellent knowledge of regulations governing the activity of pharmaceutical companies in Israel, plus good awareness of other GMP requirements e.g. EU, ICH, FDA
- Understands regulations pertaining to licensing, import/export, controlled drugs, and transportation requirements.
- Excellent working knowledge of pharmaceutical regulations applicable in Israel
- Working experience within Israel, relevant knowledge of European, USA and/or International regions is an advantage
- Experience working with contract manufacturing, testing and distribution
- Experience interfacing with regulatory bodies and working on regulatory submissions.
- High level of professional competence.
Key Skills, Abilities, and Competencies
- Ability to multi-task in environment with changing priorities
- Good interpersonal and communication skills
Able to work with many organizations / cultures / quality systems
- Solves problems whilst maintaining Quality Standards and considering Shire Policy
- Must be able to work in a fast paced environment with demonstrated ability to deal with competing tasks and demands.
- Understands total potential impact and contributes significantly to the solution of simple or complex issues arising
- Expected to work with a number of suppliers / products
- Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently
- Offers constructive comments and proposes improvements and rationalizations to systems, policies and procedures
- Uses own judgement to assess what to refer upwards and what to deal independently
- Be pro-active, prioritise and able to work with minimal supervision.High cultural awareness and sensitivity
- Effective communication skills in order to present effectively, both verbally and in writing, scientific and strategic concepts.
- Critical thinking ability and good judgement
Internal and External Contacts
Primary Internal Contacts:
- Global Regulatory Affairs
- Global Quality Assurance
- Quality Quality Control
- Supply Chain & Customer Service
- External Supplier Manufacturing
- Pharmaceutical and Analytical Development
- Process Development
- Contract Manufacturers
- Contract Distributors
- Contract Laboratories