Total 2 Affairs Manager job vacancies in Petaling Jaya

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:

• Bachelor of Life Science

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Manager, 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.

Key Responsibilities:

• Develop and implement regulatory strategy to accelerate products and indications pipeline
• Drive regulatory policy shaping initiatives with local regulatory agency, trade association and other external stakeholders.
• Ensure regulatory support through product life cycle including labelling, CMC and dossier modifications
• Coordinate the preparation of post-approval regulatory documents in accordance with agreed timeframes
• Lead/participate in negotiations during regulatory approval processes for applications with the regulatory agencies
• Participate in inter-company organizations focusing on specific industry-related issues
• Keep abreast on all regulatory requirements (local, ASEAN, ICH, WHO), market, and industry developments
• Build long term effective relationships and keeps open communication with Regional / Global colleagues
• Monitor regulatory agencies and industry changes, trends and requirements to contribute effectively to product development and regulatory strategies
• Cooperate with other departments to collect information needed for recall reporting, including initial and follow-up reports, and others
• Contribute with regulatory support during health authority site inspections
• Attend inter-departmental meetings discussing product issues and priorities to develop clear and concise plans with milestones to reach the desired outcomes
• Participate in development of regulatory strategies for product changes, to ensure compliance with the current regulatory requirements
• Participate in working and industry groups to provide input to shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations
• Serves as a local in-house CMC expert and able to provide a specialized perspective for product life-cycle management.

Education Minimum Requirement:

• Graduates with Pharmacy degree or graduates with Science related degree eg BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
• First class honours or high second upper degree
   

Required Experience and Skills:

• Registered pharmacist are encouraged to apply
• A minimum of 10 years of relevant pharmaceutical regulatory experience, preferably with MNC background, including experience in regulatory affairs policy shaping and CMC
• Ability to communicate well verbally and in writing to internal and external stakeholders is essential
• Detail oriented, meticulous and organized
• Has basic IT knowledge
• Able to work within targeted timelines
• Advanced project management skills
• Self-motivated and strong commitment to achieve desired results and right first time
• Team player

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):