Regulatory Affairs Specialist

A manufacturing pharma company is looking for Regulatory Affairs Senior Project Manager!

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.

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).