Regulatory Affairs Manager

Job Location

Petaling Jaya

Job Description

Overview of the job

You will lead Regulatory Affairs in Malaysia for Personal Healthcare. In this role, you will manage all regulatory activities in Malaysia. You will play an essential role in building clear strategic business direction, building and implementing a robust external advocacy strategy and working closely in collaboration with the multi-functional team.

Your team

This role reports to Director of Regulatory Affairs ASEAN and can look forward to being a part of the bigger ASEAN team. The team manages P&G health products of brands such as Vicks, Neurobion, Sangobion, Iliadin etc.

What success looks like

Functional performance - Effectively deliver base business, franchise innovations, accelerate regulatory approvals, external advocacy in partnership with Government Relations. Demonstrate partnership with Technical & Commercial Leadership to ensure robust business deliverables including regulatory considerations. Smooth day to day operations & timely high-quality delivery on programs across Malaysia. Robust regulatory monitoring, anticipating changes and timely implementation to meet requirements.

Career development - Working in P&G, our roles provide the opportunity to engage and grow in your career.

Responsibilities of the role

• Deliver a compliant Malaysia Healthcare business
• Collaborate with Malaysia leadership team on broad business & organization matters
• Lead local registration strategy and planning for base business & new product development to support business objectives and deliver timely approvals
• Build and maintain robust network with regulatory authorities to ensure smooth approvals.
• Ensure a robust submission dossier meeting the most current requirements is prepared in a timely manner.
• Manage internal & external approval process of new pack materials, POSM and advertisement materials
• Ensure all relevant regulatory systems and databases are maintained up to date
• Actively participate in cross functional meetings or coordination meetings for projects regionally and globally
• Stay updated with the upcoming changes in regulatory legislation and guidelines and define impact to business.
• Negotiate and take a lead in driving long term external advocacy in partnership with Government Relations and relevant industry associations.

Job Qualifications

Role Requirements

• Graduate with degree (Bachelors/Masters) in Pharmacy. Registered pharmacist is required
• Minimum 5 years experience in regulatory associated with Consumer Health products. Extended experience and knowledge with focus on OTC medicines and health supplements will be advantageous.
• Demonstrated experience dealing with and influencing related government agencies, i.e.: NPRA and Pharmacy Program Services towards successful regulatory outcomes
• Knowledge and experience in GMP, GDP regulations will be an advantage.
• Communication Skills - Able to clearly present information to non-technical leadership teams through the spoken word. Able to write and speak clearly and effectively in English to the team.
• Decision Making & Problem Solving - Able to take action in solving problems while exhibiting judgement and a realistic understanding of issues, able to use reason, even when dealing with emotional topics
• Policy and Procedures - Able to relate to routine operations in a manner that is consistent with established policies and procedures
• Analytical Skills - Able to use a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions
• Proficient in English - both written and oral.
• Proficient in Computer systems

About us

We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always, Ariel, Gillette, Head & Shoulders, Herbal Essences, Oral-B, Pampers, Pantene, Tampax and more. Our community includes operations in approximately 70 countries worldwide.

Visit http://www.pg.com to know more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor.

Job Schedule

Full time

Job Number

R000118142

Job Segmentation

Experienced Professionals (Job Segmentation)