Reg Affairs Assistant, 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 Assistant to become a prat of the Bulgarian team. As a Regulatory Affaris Assistant you will be supporting the Regulatory Affairs Specialists and internal PPD Project team in preparation, planning and coordination of regulatory documentation.

Responsibilities:

• Provides regulatory support to Regulatory Specialists and internal PPD Project team in preparation, planning and coordination of regulatory documentation from provision from a client to timely submission of final document back to client or relevant Regulatory Authorities;• Maintains tracking and status update of project in PPD and/or client databases;• Keeps colleagues and/or client informed of delayed, missing or incomplete items; ensure follow-up and completion of all transactions are performed in a timely manner.

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 Assistant to become a prat of the Bulgarian team. As a Regulatory Affaris Assistant you will be supporting the Regulatory Affairs Specialists and internal PPD Project team in preparation, planning and coordination of regulatory documentation.

Responsibilities:

• Provides regulatory support to Regulatory Specialists and internal PPD Project team in preparation, planning and coordination of regulatory documentation from provision from a client to timely submission of final document back to client or relevant Regulatory Authorities;• Maintains tracking and status update of project in PPD and/or client databases;• Keeps colleagues and/or client informed of delayed, missing or incomplete items; ensure follow-up and completion of all transactions are performed in a timely manner.

Education and Experience:• Bachelors` degree in science - related field is an advantage• Previous experience working in the pharmaceutical/ CRO industry - 1 year • General knowledge of global/ regional/ national country requirements/ Regulatory Affairs Procedures for Clinical Trial Authorization is an asset;• Very good English language skills;• Ability to read, analyze and interpret general and business periodicals, study documents, technical procedures or governmental regulations, to write reports, business correspondence and procedure manuals, and to effectively present information and respond to questions from wide range of internal and external stakeholders;• 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 environment.

At PPD we hire the best, develop ourselves and each other, and recognise the 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 development programme, 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 have a flexible working culture, where PPD truly value a work-life balance. 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 a global organisation but 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 receive many applications, sometimes we are unable to provide feedback to everyone.Diversity StatementPPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

Education and Experience:• Bachelors` degree in science - related field is an advantage• Previous experience working in the pharmaceutical/ CRO industry - 1 year • General knowledge of global/ regional/ national country requirements/ Regulatory Affairs Procedures for Clinical Trial Authorization is an asset;• Very good English language skills;• Ability to read, analyze and interpret general and business periodicals, study documents, technical procedures or governmental regulations, to write reports, business correspondence and procedure manuals, and to effectively present information and respond to questions from wide range of internal and external stakeholders;• 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 environment.

At PPD we hire the best, develop ourselves and each other, and recognise the 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 development programme, 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 have a flexible working culture, where PPD truly value a work-life balance. 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 a global organisation but 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 receive many applications, sometimes we are unable to provide feedback to everyone.Diversity StatementPPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.