Manager, Regulatory Affairs CMC

5 days ago

Hyderabad, Telangana, India MSD Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Job Description

Responsible for implementing CMC regulatory strategies for assigned products in

accordance with global regulations and guidances; and is responsible for the

preparation and submission of CMC dossiers for pipeline and commercial products.

 Accountable for the delivery of regulatory milestones for less complex projects

through the product lifecycle.

 Participate in the development, communication, lifecycle management and

review of the CMC Regulatory Strategy Document for smaller-scoped projects.

 Execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post approval

supplements, annual reports, registration renewals and responses to

health authority questions per established business processes and systems.

 Experience in reviewing scientific information and assessing whether technical

arguments are clearly presented, and conclusions are adequately supported by

data.

 Applying oral and written communication skills and the ability to communicate

issues in a succinct and logical manner. Strong listening skills.

 Applying understanding of related fields (e.g., manufacturing, analytical, quality

assurance).

 Flexibility in responding to changing priorities or dealing with unexpected events

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):

Required Skills:

Adaptability, Communication, Compliance Investigations, Documentation Standards, Electronic Common Technical Document (eCTD), Employee Training Programs, Global Regulatory Submissions, Management Process, Pharmaceutical Manufacturing, Policy Implementation, Records Retention Management, Regulatory Affairs Compliance, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Communications

Preferred Skills:

Job Posting End Date:

09/30/2025

  • A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R364297

  • Manager, Regulatory Affairs CMC

    3 days ago

    Hyderabad, Telangana, India MSD Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job DescriptionResponsible for implementing CMC regulatory strategies for assigned products inaccordance with global regulations and guidances; and is responsible for thepreparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projectsthrough the product...

  • Sr. Associate Regulatory Affairs

    7 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Career CategoryRegulatoryJob Description Job Description:Amgen is a leading human therapeutics company in the biotechnology industry.  For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.  As a Fortune 500 company serving millions of patients, Amgen continues to be an...

  • Associate Director Regulatory Affairs

    1 week ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    Associate Director Regulatory Affairs Career CategoryRegulatory Job Description What you will do The Associate Director is a senior people leader responsible for the operational effectiveness, staff engagement, and strategic alignment of Amgen's CMC & Device Regulatory Team in Amgen India (AIN). This role provides leadership across multiple...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    What you will doThe Associate Director is a senior people leader responsible for the operational effectiveness, staff engagement, and strategic alignment of Amgen's CMC & Device Regulatory Team in Amgen India (AIN). This role provides leadership across multiple functional interfaces and global sites, ensuring that AIN staff are supported, connected, and...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Career CategoryRegulatoryJob DescriptionWhat you will doThe Associate Director is a senior people leader responsible for the operational effectiveness, staff engagement, and strategic alignment of Amgen's CMC & Device Regulatory Team in Amgen India (AIN). This role provides leadership across multiple functional interfaces and global sites, ensuring that AIN...

  • Regulatory Affairs

    1 week ago

    Hyderabad, Telangana, India Shilpa Medicare Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Role & responsibilitiesCMC and Labelling:Preparation of ANDAs in eCTD format for various type of formulationsReview of the technical documents such as Specifications, BMR, MFC,Able to work on All type of CTD section write-upsHands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS)Through knowledge on ICH guidancesShould able to handle...

  • RA CMC Manager

    3 days ago

    Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description SummaryResponsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...

  • Regulatory Affairs Associate Director

    3 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years...

  • RA CMC Manager

    5 days ago

    Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    SummaryResponsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.About the RoleKey...

  • Regulatory Compliance Change Assessor

    1 week ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    To ensure appropriate regulatory oversight and evaluation of reportability for changes throughout product lifecycle. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product...