![Thermo Fisher Scientific](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Manager
2 weeks ago
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.
Responsibilities:
- Lead the preparation of global regulatory submissions and ensure high quality standards that meet local and regional requirements.
- Provides internal clients with uptodate 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 longrange 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 problemsolving 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.
-
Regulatory Affairs Portfolio Manager
2 weeks ago
Johannesburg, Gauteng, South Africa Novo Nordisk AS Full timeAre you passionate about driving changes and improvements? Do you want to be a part of a fast-growing and developing company that is dedicated to helping people? If so, we have an exciting opportunity for you to join Novo Nordisk as a Regulatory Affairs Portfolio Manager. Take the chance and embark on this rewarding career journey!This position will be based...
-
Regulatory Affairs Portfolio Manager
2 weeks ago
Johannesburg, Gauteng, South Africa Novo Nordisk Full timeExciting Opportunity at Novo Nordisk: Regulatory Affairs Portfolio ManagerLocation: Johannesburg, South AfricaReporting to: Head of Regulatory Affairs & PharmacovigilanceAbout the Position:Monitor local regulatory environment and ensure complianceCompile, submit, and approve NDA, Medical Devices, and LCM licensesReview and approve promotional...
-
Regulatory Affairs Portfolio Manager
2 weeks ago
Johannesburg, Gauteng, South Africa Novo Nordisk Full timeAre you passionate about driving changes and improvements?Do you want to be a part of a fast-growing and developing company that is dedicated to helping people?If so, we have an exciting opportunity for you to join Novo Nordisk as a Regulatory Affairs Portfolio Manager.Apply today and join us for a life-changing careerThis position will be based in...
-
Regulatory Affairs Manager
2 weeks ago
Johannesburg, Gauteng, South Africa Unique Personnel Full timeJob Number 72786Job Type PermanentJob Title Regulatory Affairs ManagerComputer Skills Ms OfficeIndustry ManufactureCity Johannesburg (Incl. Northern Suburbs)Province GautengReporting to Head: Regulatory AffairsJob purpose: Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, Gauteng, South Africa JorDan Human Resources Full timePermanent CT00417 Medical, Pharmaceutical & Nursing Gauteng, JHB Northern Suburbs R R 58000 Monthly Cost To Company (Standard Benefits ) Pharmaceutical Production Client in JHB North in need of a Regulatory Affairs Pharmacist, to ensure legal compliance with the relevant Medicine Regulatory Authorities (Country Specific where applicable) Ensure compliant...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, Gauteng, South Africa Unique Personnel Full timeJob Number 72665Job Type PermanentJob Title Regulatory Affairs PharmacistComputer Skills Ms OfficeIndustry ManufactureCity Johannesburg (Incl. Northern Suburbs)Province Gauteng Reporting To Regulatory Affairs Manager / Senior RA PharmacistJob Purpose To Support the Regulatory Affairs team with electronic compilation, documentation control and publishing of...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, Gauteng, South Africa Unique Personnel Full timeJob Number 71064Job Type PermanentJob Title Regulatory Affairs PharmacistComputer Skills Adobe Acrobat,MS ExcelIndustry ManufactureCity JohannesburgProvince Gauteng Reporting to RA Systems ManagerJob purpose Maintain applicable regulatory affairs information management electronic systems, ensuring accurate system usage and data integrity by all stakeholders....
-
Head of Regulatory Affairs
2 weeks ago
Johannesburg, Gauteng, South Africa PSM Personnel Full timeHead of Regulatory Affairs Pharmacist ~ RegulatoryJohannesburg North-GautengWe are looking for the Head of Regulatory Affairs to join our clients team of experts, a leader who has managed people for a minimum of 5 years. Someone who will oversee the development and delivery of a fully integrated regulatory strategy for the business. In this role, you will...
-
Head of Regulatory Affairs
2 weeks ago
Johannesburg, Gauteng, South Africa Unique Personnel Full timeJob Number 71851Job Type PermanentJob Title Head of Regulatory AffairsComputer Skills Ms OfficeIndustry ManufactureCity Johannesburg (Incl. Northern Suburbs)Province GautengReporting To Managing Director - company OTCJob Purpose The Head of Regulatory Affairs holds ultimate responsibility for the company OTC division's regulatory activities and oversees the...
-
Regulatory Affairs
2 weeks ago
Johannesburg, Gauteng, South Africa Danone Full timeAbout the jobManage all Regulatory Affairs and Category Compliance activities on behalf of Danone Nutricia Africa (DNAF) for Southern Africa & export countries within the scope of Specialized Nutrition (SN) division: baby food products and medical nutrition.Protect and support Danone's business and assets by designing and implementing the optimal regulatory...
-
Head of Regulatory Affairs
2 weeks ago
Johannesburg, Gauteng, South Africa Johnson & Johnson Full timeThe Head of Regulatory Affairs ZA will be responsible for leading regulatory affairs activities in the cluster for the Janssen portfolio and support local GPH regulatory team as required striving for convergence in ways of working.The position may also have Local QP responsibility.Reports to: Direct line to Managing Director ZA Dotted to Snr Director...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, Gauteng, South Africa Johnson & Johnson Full timeREGULATORY AFFAIRS PHARMACISTLocation: GautengContract: PermanentThe responsibilities & the impact YOU will have:SummaryTo effectively complete all required Regulatory tasks relating to product registrations and dossierlifecycle maintenance for products the local operating company (LOC) has regulatory responsibility and to ensure these tasks are performed in...
-
Head of Regulatory Affairs
2 weeks ago
Johannesburg, Gauteng, South Africa Ultra Personnel Full timeEssential Skills and Experience RequiredQualifications: B. Pharm Degree Registration with South African Pharmacy Council, MS or PhD in life sciences or related field is required.A minimum of 8 years of pharmaceutical regulatory experience is a prerequisite with excellent knowledge and understanding of the current pharmaceutical industryMinimum of 5 years in...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, Gauteng, South Africa Johnson & Johnson Full timeWe are currently hiring a Regulatory Affairs Pharmacist for our South African office, to be based in Johannesburg in a hybrid work model.Teamwork at the organization will help you grow with world-class training, as well as our educational programs and the opportunities they offer.Key Responsibilities: Effectively complete all regulatory tasks from new...
-
Regulatory Affairs Specialist
2 weeks ago
Johannesburg, Gauteng, South Africa Abbott Laboratories Full timeJob TitleRegulatory Affairs Specialist (1-Year Fixed-Term Contract)About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, Gauteng, South Africa Servier Full timeDate posted:28 Feb 2024City:JohannesburgCountry/Region:ZAType of Contract:PermanentJob Requisition ID:5374Regulatory Affairs Pharmacist- .REGULATORY AFFAIRS PHARMACISTJOB OVERVIEW**: Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain Servier's...
-
Senior Regulatory affairs pharmacist
2 weeks ago
Johannesburg, Gauteng, South Africa Curiska Full timeJOB TITLE: Regulatory Affairs PharmacistCOMPANY: Pharmaceutical CompanyDESCRIPTION: Join our team as a Regulatory Affairs Pharmacist to ensure a smooth product registration process and compliance with all regulations. Your role involves overseeing regulatory documentation, managing safety updates, and maintaining pharmacovigilance requirements.DUTIES AND...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, Gauteng, South Africa Six Sense Full timeGauteng, JHB - Eastern Suburbs Annually Cost To Company (Market related)Well established Pharmaceutical business seeking to appoint a Regulatory Affairs Pharmacist.Minimum Requirements: Bachelor's degree in Pharmacy, registered with the South African Pharmacy Council MSc, MBA or PhD may be an advantage Experience in regulatory affairs, preferably in human...
-
Regional Regulatory Affairs Manager
2 weeks ago
Johannesburg, Gauteng, South Africa Boston Scientific Corporation Full timeWork mode:HybridOnsite Location(s):Johannesburg, South AfricaAdditional Locations: South Africa-Johannesburg; Bucharest-Romania; Lebanon-Beirut; Turkey-IstanbulDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full timeJOB OVERVIEW:Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements.DUTIES AND RESPONSIBILITIES: Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist Ensure and supervise that...