Scientist Regulatory Affairs Cmc

Scientist Regulatory Affairs CMC
- Join the **premier biopharmaceutical company **that has been in **AP for over 60 years.**

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.

The Scientist is responsible for developing regional CMC strategy, preparation of CMC

documentation and execution of regional post-approval CMC submissions and new product

registration. It serves as a link between regional Local Regulatory Affairs, CMC Product Teams

and GRACS CMC teams.

**WHAT YOU WILL DO**
- Responsibilities include, but are not limited to:_

**Primary Activities include but are not limited to**:
changes

Delivers regional regulatory change control assessment identifying regulatory

requirements for CMC submissions

Prioritizes submissions as per global regulatory strategy coordinating with local regulatory

colleagues to support the business

Seeks opportunities to maximize submission efficiency and quality to ensure a high rate of

submission approvals by Health Authorities

Track submissions and approvals ensuring bidirectional communication of status with local

affiliates and global CMC teams

Prepares documentation to support submission according to local/regional requirements

Prepares timely responses to Health Authority questions ensuring compliance against

local/regional regulatory requirements

Represents regional CMC on cross-functional teams to ensure mutual understanding of

local/regional CMC requirements and program complexities, maintaining close

communication with regional and local regulatory colleagues, regional Supply Chain teams

and global CMC teams

Supports product compliance by ensuring local registrations and lifecycle management

align with product manufacturing details

Supports continuous process improvement activities within the organization and

participate in forums to ensure efficient processes and best practice.

Ensures awareness of regional regulatory policy trends and maintaining the regulatory

intelligence repository for regional markets

Identifies, communicates, and escalates potential regulatory issues management, as

needed

**WHAT YOU MUST HAVE**

To be successful in this role, you will have:
Bachelor’s (minimum) or graduate degree (preferred) in chemistry, biological science,

engineering, or a related field. Fields of study include Pharmacy, Chemical Engineering,

Biology, Microbiology, or Biochemistry or other similar scientific discipline

At least three (3) years of relevant experience in research, manufacturing, testing, or regulatory CMC; and/or related fields

Proficiency in English; additional language skills are a plus

**WHAT YOU CAN EXPECT**
- Regional exposure
- Handling of international markets

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

**Who we are **

We are known as Merck & Co., Inc., Rahway, 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.

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..

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