Regulatory Affairs Senior Project Manager - 213

Job Duties and Responsibilities

The main function of the Regulatory Affairs Senior Project Manager is providing regulatory oversight and input on the company’s non clinical and clinical development plan, company strategy and regulatory submissions to ensure that products, which are developed, manufactured or distributed by the company, comply with the required regulatory legislations in US, EU and ROW.

The position involves the following activities:

1. Act as primary contact for the cross functional product development teams, providing regulatory guidance during non clinical and clinical development stages and recommend regulatory pathway throughout product development.

2. Lead ongoing communications with Health Authorities (EMA and FDA)

3. Preparation and review of regulatory documents including but not limited to Scientific Advice, IMPD, regulatory meeting documents, etc. Ensure documents are in compliance with current regulations and guidance.

4. Collecting, collating and evaluating scientific and technical data generated by the relevant product development team (non-clinical, clinical and medical information).

5. Planning and preparation of CTD based regulatory submission in Europe and in the USA (INDs, BLA, MAA) for new products, to ensure the timely approval for clinical studies and marketing applications.

6. Ensure completeness and accuracy of regulatory submissions.

7. Involvement in the planning and development of company strategy on assigned programs and communicate regulatory goals.

8. Provide global support for marketing teams and operations teams in different markets.

9. Maintain current regulatory knowledge of regulations, guidelines, and standards.

10. Responsible for routine regulatory maintenance work (Annual reports in US, Europe and Israel) as per local regulatory requirements.

11. Set and monitor timelines for regulatory procedures and submissions.

12. Coordinate team review of regulatory documents and manage the organization, compilation and publishing of regulatory submissions to competent authorities in EU, FDA and Rest of the Word.

13. Identify and assess regulatory risks and project issues as well as recommend solutions to the project teams.

Required Education, Experience and Qualification:

• Education: PhD/PharmD/MSc life science degree or pharmacy degree.

• Candidate should have at least 5 years hands-on experience in Regulatory Affairs within the pharmaceutical industry (preferably biological products), preference for innovative pharmaceutical company.

• Previous experience in clinical and non-clinical aspects of product development; knowledge in manufacturing processes and GMP compliance is an advantage.

• Previous experience in authoring/reviewing of the preparation and filing of regulatory submissions (e.g. CTD clinical, non-clinical and quality modules) for global development activities ultimately leading to BLA/MAA submissions/approvals.

• Knowledgeable in FDA, EMA and ICH guidelines relevant to clinical and non-clinical aspects of product development and maintenance.

• Intelligent and creative, quick learner with a positive mind set and start up mentality.

• Independent and highly motivated.

• Excellent communications skills, be able to work under pressure to tight timelines.

• Attention to details and well organized person.

• Fluency in English (mother tongue proficiency).