Regulatory Affairs Manager
Found in: Talent SG C2 - 2 weeks ago
Description
Job Title: Regulatory Affairs Manager
Location: Singapore
About the role:
The job requires the person to manage Regulatory Affairs for all Company products to ensure they are in compliance with statutory and company requirements and maximize the contribution of Regulatory Affairs to the achievement of business objectives through active assistance in the development and implementation of the company’s policy positions and product advocacy strategies.
How you will contribute:
RA registered pharmacist for Singapore LOC
Plan, strategize and monitor regulatory filings for timely submissions and approvals of new product registrations and variation applications.
Life cycle management of existing product portfolio while ensuring smooth supply of products
Manage labeling changes, safety updates, artwork development and artwork approval of packaging material components.
Build effective working relations with the regulatory agency and follow-up closed on approval of products registration and variations
Work with all appropriate local functions to develop and implement the best regulatory strategies/plans to support commercial goals and product launch excellence.
Develop annual regulatory budget for Singapore filings/variations/registrations/license renewals.
Review promotional material in relation to product campaign launches and ongoing product marketing activities.
Support regulatory review or artwork/promo material/ad-hoc requests for partners’ products
Update and maintain local and global-associated databases with Malaysia & Singapore regulatory information.
Keep tracking of policy changes, current and emerging issues, understand their potential impact on business and build corresponding strategies to support business
Develop and maintain good and effective relations with local authorities and pharmaceutical associations
Participate in local authority inspections and internal audits when applicable to the regulatory affairs function.
Assist Head of Regulatory Affairs, MYSG on regulatory assignments as and when required.
Specific Competencies
Highly organized and self-disciplined
High level of integrity and good morals.
Innovative and resourceful with excellent analytical and problem-solving skills
Excellent communication and facilitation skills
A good team player with excellent interpersonal skills
Excellent written and oral communication skills in English
What you bring to Takeda:
Registered pharmacist in Singapore
Minimum Bachelor's degree in Pharmacy
A minimum of 3 years of relevant Regulatory Affairs expertise in the pharmaceutical industry
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
Knowledge of national legislation and regulations relating to medicinal products
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Locations
Singapore, Singapore
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time-
Assistant Manager, Clinical and Regulatory Affairs
Found in: Talent SG 2 C2 - 1 week ago
Singapur, Singapore ADVANCED OPHTHALMIC INNOVATIONS PTE. LTD. Full timeRoles & Responsibilities· Responsible for activities related to the Company’s regulatory management systems, including coordinating, training, developing, improving, and implementing existing and new regulatory pathways.· Prepares, submits, tracks, indexes and archives electronic submissions including information, amendments, annual reports, general...
-
Regulatory Affairs Specialist, SEA
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Arthrex Full timeDescription Benefits & Highlights: Work Style: Hybrid/Flex Location: Buona Vista Great employee benefit Weekly office lunches Reporting Line: Regulatory Manager, APAC About the Role: - Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying...
-
Regulatory Affairs Intern
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Philips Full timeJob TitleRegulatory Affairs InternJob DescriptionIn this role, you have the opportunity to make life betterLooking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.You are...
-
Manager-Government Affairs
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Lazada Full timeDepartment: Corporate Management Location: Singapore Department: Corporate Management Location: Singapore Job Description In this role, you’ll be the government affairs representative who will bring to life Lazada’s meaningful impact and solid corporate reputation in Singapore. This will include efforts to build profile among government and...
-
Head of Corporate Affairs
Found in: Talent SG C2 - 3 weeks ago
Singapur, Singapore Marina Bay Sands Full timeJOB SCOPE The Head of Corporate Affairs is responsible for implementing and maintaining Marina Bay Sands’ strategic corporate affairs plan and approach, aimed at enhancing engagement with the Singapore Government and other important external stakeholders. Reporting to Vice President Communications & Corporate Affairs, responsibilities include : ...
-
Senior Specialist, Regulatory Affairs
Found in: Talent SG C2 - 3 weeks ago
Singapur, Singapore Baxter Full timeThis is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Senior Manager, Government
Found in: Talent SG C2 - 3 days ago
Singapur, Singapore Micron Full timeOur vision is to transform how the world uses information to enrich life for all. Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it...
-
Sr. TPM, Asia Pacific
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Amazon Kuiper Singapore Private Limited - R52 Full timeProject Kuiper is an initiative to launch a constellation of Low Earth Orbit (LEO) satellites that will provide low-latency, high-speed broadband connectivity to unserved and underserved communities around the world. We require licenses in each country where we will provide Kuiper services, but there is no globally unified regulatory licensing regime for a...
-
Medical Affairs Lead, Oncology, HP ROPU ASKAN
Found in: Talent SG C2 - 3 weeks ago
Singapur, Singapore Boehringer Ingelheim Full timeThe PositionThis person will be responsible for the Medical Affairs strategy and execution in ROPU ASKAN Oncology therapeutic area (TA).Duties & ResponsibilitiesWork closely with the OPU brand teams together with regional marketing team, develop, implement, and execute strategies and activities to bring the benefit of BI medications to patients across the...
-
Customer Affairs Manager
Found in: Talent SG C2 - 3 weeks ago
Singapur, Singapore Singapore Airlines Full timeJob DescriptionThe successful candidate will be part of the Customer Affairs department in SIA's Customer Services & Operations Division. Key Responsibilities Play an important role in managing and building relationships with SIA customers. Attend to customer feedback promptly and take actions to restore customer confidence. Work closely with various...
-
Manager, Digital Legal Affairs, APAC
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Warner Music Group Full timeManager, Digital Legal Affairs, APACJob Description:At Warner Chappell Music (WCM), we shape the culture of songwriting and champion songs that resonate for generations by creating transformational opportunities for songwriters everywhere. Our people and culture are at the epicenter of our company, and we are looking for team members who share our...
-
Public Affairs Project Officer
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Timeo-Performance Full timeJob DescriptionJob Overview: Our client is a global semiconductor leader and they have engaged Timeo to recruit their Public Affairs Project Officer, based in Singapore (a newly created position). Reporting to the Senior Manager of Public Affairs for Southeast Asia, you will focus on enhancing the organization's profile and reputation among external...
-
Public Affairs Project Officer
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Timeo-Performance Full timeJob Overview: Our client is a global semiconductor leader and they have engaged Timeo to recruit their Public Affairs Project Officer, based in Singapore (a newly created position). Reporting to the Senior Manager of Public Affairs for Southeast Asia, you will focus on enhancing the organization's profile and reputation among external stakeholders by...
-
Foreign Service Officer
Found in: Talent SG C2 - 3 weeks ago
Singapur, Singapore Ministry of Foreign Affairs Full timeJob Scope You will analyse, report and give policy advice on geopolitical developments concerning Singapore’s strategic interests. You could be deployed to manage bilateral or multilateral relations, and responsibilities could include: Representing Singapore in visits, meetings, conferences and bilateral/multilateral negotiations Coordinating...
-
Supervisor/Assistant Manager Regulatory, Cosmetic Asia
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Sensient Technologies Full timeAs a Regulatory Supervisor/Assistant Manager within the Personal Care and Speciality Markets Regulatory Team based in Asia, your will ensure to lead the Asian Sensient team in accordance with worldwide chemical and cosmetic regulations and standards. You will especially be involved in a global team and be sure to comply with the harmonized processes and add...
-
Executive, Corporate Affairs
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Suntory Beverage & Food France Full timeJob Summary Suntory is a global leader in consumer-packaged goods, renowned for producing and distributing a uniquely diverse portfolio of beverages, premium spirits, beer, wine, and wellness products throughout the world. With a history dating back to 1899, we are driven by a profound purpose: To inspire the brilliance of life, by creating rich...
-
Healthcare Quality
Found in: Talent SG 2 C2 - 1 week ago
Singapur, Singapore FLINTEX CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesHealthcare Quality & Regulatory Compliance Specialist (Hybrid) AMEAOpportunity:Play a critical role in driving compliance and quality programs for Healthcare Transportation and facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and...
-
Senior Director, Public Affairs, APAC
Found in: Talent SG C2 - 3 weeks ago
Singapur, Singapore Edwards Lifesciences Full timeLead and responsible for the integrated team of Market Access and Government Affairs and being the strategic partner for local Government, Healthcare Institutes, Hospitals, Patients and Business Units to enable and improve market access of innovative therapeutic solutions for Edwards technologies and ensure the success of healthcare policy engagement. How...
-
Foreign Service Officer
Found in: Talent SG C2 - 1 week ago
Singapur, Singapore Ministry of Foreign Affairs Full timeJob Scope As a Foreign Service Officer (Functional and Corporate), you formulate, review and implement policies that impact MFA's vital operations. You are rotated to manage core functions in the following: Consular: Provide assistance to overseas Singaporeans in distress Protocol: Facilitate State formalities and courtesies Human...
-
Research Engineer I
Found in: Talent SG C2 - 3 weeks ago
Singapur, Singapore Nanyang Technological University Full timeThe Future Ready Food Safety Hub (FRESH) serves as Singapore’s lead scientific platform under the Singapore Food Story R&D Programme, to bring together researchers, regulators and industry to build up Singapore’s food safety science and R&D capabilities to secure Singapore’s food supply and economic value proposition. FRESH will embark on R&D and...