Regulatory Affairs Manager

7 days ago

Johannesburg, South Africa Thermo Fisher Scientific Full time

PPD, part of Thermo Fisher Scientific, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose
- to improve health

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — 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.

We are currently seeking a Regulatory Affairs Manager to join our global Regulatory Affairs department, Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.

Regulatory Affairs Manager - CTA (Clinical Research Field)

You will be part of a global team providing innovative regulatory solutions, owning regulatory affairs responsibilities, and leading discussions with internal and external clients. You will also be coordinating global regulatory strategies on assigned (Phase 1 to 4) clinical trials, studies and projects and providing the technical/ project leadership across regions, supporting our clients with strategic regulatory intelligence, and guidance for the product development mainly during the clinical phases. The role also supports and leads the preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements, also acts as liaison with internal and external clients.

You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings.

**Responsibilities**:

- Lead the preparation of global regulatory submissions and ensure high quality standards that meet local and regional requirements.
- Provides internal clients with up-to-date legislation and guidance as it becomes available.
- Ensure quality performance for key/managed projects.
- Manage project budgeting/forecasting functions.
- Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications.
- Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments.
- Provides matrix/project leadership, training and guidance to junior team members.
- Ensure compliance with relevant organizational and regulatory SOPs and WPDs.
- Participate in launch meetings, review meetings and project team meetings.

**What the role requires you to have**:

- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job, at least 5 years.
- Proven project management experience, and experience performing effectively in a client facing role

**Knowledge, Skills and Abilities**:

- Excellent English language (written and oral) communication skills as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Excellent negotiation skills
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc.
- Superb understanding of medical terminology, statistical concepts, and guidelines
- Excellent analytical, investigative and problem-solving skills
- Excellent understanding of budgeting and forecasting

At PPD Clinical Research Services 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

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