Regulatory Affairs Specialist, Bulgaria

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our Regulatory Affairs Department is looking for Regulatory Affairs Specialist to become a prat of the Bulgarian team. As a Regulatory Affairs Specialist you will be providing regulatory advice and carries out projects in the provision of regulatory affairs services.

Responsibilities:

· Acts as liaison with internal and external clients in the provision and marketing of these services.

Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess regulatory documents, review and assess scientific literature.

· Interfaces with PPD project teams, sponsors, and –Health Authorities regarding regulatory strategy/submission activities.

Develops and maintains a cooperative working relationship with Project Managers and project team members for assigned projects. Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities. Acts as primary liaison between Regulatory Affairs Department and project team for assigned protects.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our Regulatory Affairs Department is looking for Regulatory Affairs Specialist to become a prat of the Bulgarian team. As a Regulatory Affairs Specialist you will be providing regulatory advice and carries out projects in the provision of regulatory affairs services.

Responsibilities:

· Acts as liaison with internal and external clients in the provision and marketing of these services.

Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess regulatory documents, review and assess scientific literature.

· Interfaces with PPD project teams, sponsors, and –Health Authorities regarding regulatory strategy/submission activities.

Develops and maintains a cooperative working relationship with Project Managers and project team members for assigned projects. Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities. Acts as primary liaison between Regulatory Affairs Department and project team for assigned protects.

Education and Experience:

• Bachelor's Degree; degree in Pharmacy or Life Science is an advantage

• Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered

• Some regulatory affairs experience is preferable but not mandatory

• An appreciation of the requirements, timelines and processes for regulatory applications worldwide is a valuable asset.

• Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage.

• Excellent English language communication skills, both verbal and in writing.

• Computer skills (Microsoft office) and experience in applications used in clinical trials (eTMF, CTMS) would be an advantage

• Good organizational and planning skills. Ability for multiple project tasking

• Proven ability to work effectively in a team, including in a multinational one

• Problem solving skills and strong attention to detail

At PPD we hire the best, develop ourselves and each other, andrecognizethe power of being one team.We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and developmentprogramme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We haveaflexible working culture, where PPD truly value a work-lifebalance.We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.We are aglobalorganizationbut with a local feel.

-We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD-

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application– we’d love to hear from you.

As we are likely to receivemany applications, sometimes we are unable to provide feedback to everyone.

Education and Experience:

• Bachelor's Degree; degree in Pharmacy or Life Science is an advantage

• Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered

• Some regulatory affairs experience is preferable but not mandatory

• An appreciation of the requirements, timelines and processes for regulatory applications worldwide is a valuable asset.

• Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage.

• Excellent English language communication skills, both verbal and in writing.

• Computer skills (Microsoft office) and experience in applications used in clinical trials (eTMF, CTMS) would be an advantage

• Good organizational and planning skills. Ability for multiple project tasking

• Proven ability to work effectively in a team, including in a multinational one

• Problem solving skills and strong attention to detail

At PPD we hire the best, develop ourselves and each other, andrecognizethe power of being one team.We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and developmentprogramme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We haveaflexible working culture, where PPD truly value a work-lifebalance.We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.We are aglobalorganizationbut with a local feel.

-We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD-

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application– we’d love to hear from you.

As we are likely to receivemany applications, sometimes we are unable to provide feedback to everyone.