at PPD in Berlin, United States
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.
PPD has an exciting opportunity for a Regulatory Affairs Senior Manager/Associate Director to join us exclusively for one of our strategic partners.
The role would support the teams in preparation of Regulatory submissions including CTAs/briefing documents for US and EU, IMPD, IND.
The position will have the following key responsibilities:
- Prepares and/or reviews documents for completeness and accuracy; interacts with project team members to assure completeness and timing with regulatory process.
- Prepares inventory documents based on checklists prepared by regulatory personnel and /or CRO.
- Prepares and/or reviews regulatory documents for Agencies in US, EU or ROW with R&D team members.
- Conducts initial review of regulatory agency publications.
- Prepares and distributes regulatory agency contact reports and meeting minutes.
- Arranges meetings for regulatory part within project teams or regulatory agency.
- Increases knowledge of regulations and guidelines and shares new information with regulatory team.
- With oversight, conducts QC checks of materials prepared by the project team or external.
- Assists with project management, and other tasks as required by regulatory team members.
- Attends regular project team meetings.
- Develops regulatory strategy and prepares and conducts Agency meetings
- Takes care of the development of risk assessment and risk mitigation
- Filing of all matters related to nonclinical reports and clinical trials for regulatory activities from Phase 1 to 3 according to CTD.
- Supports in preparation of activities prior to BLA/MAA.
- Provides responses to regulatory agencies with support of the project team. Ensure that the document content is aligned with regulatory expectations in US, Japan and EU.
Education and Experience Requirements:
- Significant relevant regulatory experience in clinical research and drug development
- Project management experience and experience successfully building relationships across a diverse stakeholder team
- Experience with global CTA and MAA submissions, scientific advice PIPs, orphan drug applications
Knowledge, Skills and Abilities:
- Knowledge of budgeting and forecasting
- Excellent interpersonal skills – able to work well and build relationships across a diverse set of stakeholders and characters
- Sound judgement and ability to analyze situations and information. Takes decisions based on facts and figures rather than on assumptions.
- Effective oral and written communication skills
- Good organizational and planning skills
- Good negotiation skills
- Ability to work on own initiative
- Ability to motivate and integrate teams and teach/mentor team members
- Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures
- Ability to act as liaison with other departments where necessary
- Flexible mindset and resistant to stress and changes in strategy.
- Able to travel based on business needs.
- Medical writing skills is an asset.
- Fluent in English (oral and written).
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 anaward-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 aflexible 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.
Job: Regulatory Affairs
Organization: GB BU
Title: Regulatory Affairs Senior Manager/Associate Director – Customer Dedicated
Location: GB-GB-Cambridge-Cambridge GB Granta Park1
Requisition ID: 204261
Other Locations: DE-DE-Munich-Munchen DE Hansastrasse, FR-FR-Nantes, BE-BE-Brussels-Brussels BE St Stevens Woluwe, NL-NL-Bennekom, IE-IE-Athlone, FR-FR-Bordeaux, IT-Italy, NL-Netherlands, NL-NL-Bennekom-Bennekom NL Bornweg 12c, DE-DE-Berlin, BE-BE-Zaventem, GB-GB-Winchester-Winchester GB 1-2 Crown Walk, FR-FR-Lyon, ES-ES-Madrid-Madrid ES – Titan, 15, GB-GB-Bellshill-Bellshill GB Fleming House 1, BE-BE-Belgium, DE-DE-Karlsruhe-Karlsruhe DE, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, FR-FR-Marseille, ES-ES-Madrid
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group