Job Description
Specialist, Regulatory Affairs
Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
Join the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years.
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. Our company’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Role Summary
Responsible to support the day-to-day operations of Asia Pacific Labeling & Artwork Hub. Perform tasks as requested by the participating countries, to deliver labelling and artwork tasks in accordance with our company’s labelling and artwork guidelines, including but not limited to:
• Evaluation of labeling activities
• Coordination with Country Regulatory Affairs’ points of contact
• Preparation of labeling content, solicit internal review & approval, as appropriate
• Creation of artwork to support regulatory submissions and market implementation
• Ensure compliance at all times
Key Responsibilities:
• Product Label Management
- Ensure that product labelings are updated in accordance with respective country and corporate guidelines.
- Ensure proper maintenance of tools and systems used in the creation and maintenance of labeling materials and artworks e.g., REDS, BWEL, Artwork Management System as well as associated databases and team sites.
- Ensure prompt availability of labels and artworks and liaises with departments such as Business Development, Medical, Marketing, Training, PV and external partners to ensure compliance with established regulations.
- Ensure communications with business partners and the archival of such communications meet corporate guidelines.
- Support participating countries to ensure prompt implementation of labeling changes (safety and non-safety) for marketed products and liaise with various packaging sites, artwork centers and internal departments, for compliance with established regulations and to prevent stockout and minimize discards.
- Maintain databases and team sites by ensuring updated and accurate information are uploaded.
• Compliance
- Drive compliance according to participating countries’ set procedures and standards by ensuring required metrics are met.
- Ensure efficient execution of strategic regulatory and implementation plans to achieve the desired results and avoid stock-outs.
- Ensure deliverables are achieved as planned to quality and timeliness targets
• Individual must possess
- A quality mindset
- Strong orientation to details
- Proactive
- Flexible
- Results-oriented
- With very good communication skills
Education Minimum Requirements:
Required Experience and Skills:
- At least three (3) years of experience in multinational companies with knowledge on drug product registration and lifecycle maintenance
- Excellent English oral and written communication skills and presentation skills
- Planning and Project Management o Plans & coordinates works/projects and manages planning processes, techniques and practices to track progress and achieve desired goals.
- Communication o The ability to communicate effectively across a range of written and oral situations, related particularly to the creation of understanding around complex or contentious issues.
- Technical Expertise o Understands, applies, performs tasks and improves technical knowledge and skills related to area of expertise to achieve outcomes
- o Knowledge of drug product manufacturing & quality assurance
- o Strong background of prevailing regulatory guidelines and requirements
- o Knowledge of participating countries labeling and artwork regulations and process
- o Literacy in computer operation, particularly with Microsoft applications
- Act with Courage and Candor: Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.
- Demonstrate Ethics & Integrity: Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
- Drive Results: Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
- Foster Collaboration: Actively listen and seek to understand differing perspectives; work together to achieve the common goals of our company.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Remote
Shift:
Valid Driving License:
Hazardous Material(s):
