Niraj Mehta, Phd Email & Phone Number

Washington, Dc, Us

Rahway, New Jersey, Us

Rahway, New Jersey, Us

• Identify specific external policies/regulations and regulatory/industry trends that may impact MMD’s business including developing tools and strategic plans to execute the implementation of critical policies/regulations/guidelines, promoting opportunities to transform the business (e.g., monitoring global compliance risk), and monitoring Global Market Access and Government Affairs concerns impacting GQ.• Manage MMD Quality’s regulatory intelligence and external affairs activities which include executing industry/regulatory initiatives, meeting with other industry experts and global regulators as part of trade association programs, and keeping track of evolving compliance-related changes/trends by reviewing health authority inspection observations, FDA Warning Letters, and EMA Statements of Non-compliance. • Play a key role in MMD’s external advocacy program which includes participation as Merck’s quality and regulatory expert on industry association working groups (e.g., leading industry working group on mobile manufacturing) and senior leader workshops on “hot topics in industry” such as quality manufacturing maturity/metrics and post approval change innovation for availability of medicines program. • Co-chair for the Integrated Policy Council for CMC & Quality (IPC) responsible for the escalation of high impact policy matters and advocating for topics that may potentially impact MMD and Merck Research Laboratories (MRL).• Lead MMD’s Network Observation Sharing (NOS) program informing MMD about critical health authority observations and internal audit findings given to Merck’s manufacturing sites.• Lead special projects/teams responsible for investigating potential inefficiencies and conducting root cause analyses of functions within MMD (and MRL), including reviewing open change control requests and eliminating redundant testing on importation requirements by product and across MMD sites.

Silver Spring, Md, Us

Under the guidance of the Office of the Commissioner, serves in a key capacity to manage and execute the Mutual Reliance Initiative, a priority alliance for FDA senior leadership. The Mutual Reliance Initiative is a strategic partnership between the U.S. and European Union (EU) to determine if the parties could enter into a Mutual Recognition Agreement to rely on each other’s drug manufacturing inspections. As part of the Mutual Reliance Initiative, collaborated with United States Trade Representative to negotiate terms of an agreement with the EU, including DG Sante (European Medicines Agency) and DG Trade, and drafted language for key sections of the Amended Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. This "first of its kind" agreement was finalized in March 2017 and successfully implemented on November 1, 2017.

Silver Spring, Md, Us

Supervised a team of policy experts drafting technical documents (e.g., standard operating procedures, Agency-wide guidances, compliance program guidance manuals, compliance policy guides, and manual of policies and procedures) related to product quality and Good Manufacturing Practice.

Silver Spring, Md, Us

Integral member of the Mutual Reliance Initiative team that evaluated both FDA and EU’s regulatory and procedural frameworks for inspections of drug manufacturers.

Silver Spring, Md, Us

Assembled and supervised teams from across the FDA that developed and implemented novel regulatory policies and regulatory policy including standardizing enforcement and compliance procedures across bioresearch monitoring inspection programs (i.e., Good Clinical Practice, Bioequivalence, Good Laboratory, and Animal Rule Study inspections). Additionally, conducted mission critical, data integrity inspections (both domestic and foreign) under the bioresearch monitoring program.

Silver Spring, Md, Us

Experienced pharmacology reviewer for over 100 research and commercial Investigational New Drug (IND) applications (including new molecular entities) and pre-IND submissions, and New Drug Applications and Biologic License Applications related to Gastroenterology and Orphan Drug Products. Review work led to approvals of drugs such as LINZESS (Forest Laboratories, linaclotide capsules) and VIOKACE (Axcan Pharma US, pancrelipase tablets).

Doctor Of Philosophy (Ph.D.), Pharmacology

Bachelor Of Science (Bs), Biology, General