Regulatory Affairs specialistMSD

Job Description
Regulatory Affairs
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
WHAT YOU WILL DO
Compliance
For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to the company standard and local standards and relevant Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.
Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
Ensures that files and archives related to Regulatory are kept updated and complete.
Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
Editing and labelling
In connection with submission of MA applications and post-approval submissions provides translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and ensures quality assurance including linguistic check of these documents.
The above-mentioned tasks are performed under supervision of the line Manager
Artwork
Prepares artwork, including package leaflets and all other components in a timely and correct manner and according to relevant Artwork Management procedures.
The incumbent ensures proof reading of packaging components and is responsible for maintaining an updated file on packaging components, as applicable.
Cross-functional activities, as assigned
Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
Regulatory policy & environment, as assigned
Keeps abreast of local and international laws.
Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with the company's interests.
Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with the Regional Policy Team.
Participates in internal local regulatory workgroups on selected issues.
Local
Conducts initial review of Packaging Instructions, specifications and reference standards for Third Party repackers/distributors.
Handles periodic review and updating of product information for Medical Publications: MIMS, PPD, etc.
Maintains updated authenticated regulatory-related bidding documents
Maintains GMP Certificates.
WHAT YOU MUST HAVE
2 years+ related experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.
Must be a Registered Pharmacist
Must hold a B.Sc. in Pharmacy or other life science or equivalent .
Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
The incumbent should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.
Must be able to work both alone and as part of a team and have the ability to concentrate on large volumes of written/paper-based work in an office environment.
The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
WHO WE ARE
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
WHAT WE LOOK FOR
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
Current Employees apply
Current Contingent Workers apply
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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: Domestic
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings: 1
MSD

Makati City, Metro Manila
Permanent
Full-time