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Location

India | India

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Job description

Job Description

Job Description

Assistant Manager, CMC

Assistant Manager, CMC – Regulatory Affairs will be a part of the GRACS team which supports regional CMC strategy, preparation of CMC documentation. Under the direction of the area supervisor, responsible for the planning, preparation, and release of regulatory submissions (IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, etc.) and administration of associated GRACS-CMC systems and processes for the progression of commercial/non-commercial manufacturing change controls from initial authorization throughout the project’s lifecycle in the Planning, Dossier Management, Manufacturing Change Control, and Health Registration Management Systems support to ensure right at first-time submissions.

The primary activities include but are not limited to the following:

• Supports CMC regulatory strategies for post-approval changes.
• Supports regulatory change control assessment identifying regulatory requirements for CMC submissions.
• Review documentation to support submission according to regulatory requirements.
• Assists timely responses to Health Authority questions resulting from post-approval submissions and ensures compliance against regulatory requirements.
• Attends cross-functional meetings providing input on CMC requirements.
• Supports product compliance by ensuring registrations and lifecycle management align with product manufacturing details.
• Provides input on continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
• Ensures awareness of regulatory policy trends.
• Identifies, communicates and escalates potential regulatory issues management, as needed.
• Utilize GRACS and/or our Manufacturing Division systems to progress and track activities related to Change Control, Dossier planning and content management, and Health Registration Management
• Update regulatory tools and databases on a routine schedule following the guidance of the CMC scientist to ensure timely delivery of assigned activities.
• Assist in the development and continuous improvement of business processes, tools, systems, metrics, and analytics under the supervision of the manager.
• Provide support for other CMC projects and activities as needed.

Qualification:

M. Pharm Fresher (Pharmaceutics/ Pharmaceutical Analysis/ Regulatory Affairs)

Must be proficient in English; additional language skills are a plus.

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.

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

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Salary