Merck & Co Hiring Manager - Regulatory Affairs CMC Bachelor’s in Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry Apply Now
Job Description
This Role is responsible for implementing CMC regulatory strategies
for assigned pharmaceutical products in accordance with global regulations,
guidance’s and defined regulatory strategies. He would even be responsible for
the preparation and review of information required for development of
regulatory CMC dossiers for commercial products.
Our Regulatory Affairs team bring new medical advancements to the
world by facilitating communications and procedures that allow swift, organized
compliance across regulatory agencies. We are an international network on the
leading-edge of healthcare breakthroughs that help provide new, reliable, and
compliant medical products, practices and solutions to the world.
Your role at our organization is integral to helping the world meet
new breakthroughs that affect generations to come, and we’re counting on your
skills and inventiveness to help make meaningful contributions to global
medical advancement.
Primary responsibilities include, but are not limited to:
Regulatory
Responsibilities:
Provide input to global product and project regulatory strategies by
performing assessments of CMC changes, identifying global regulatory
requirements and critically evaluating supporting documentation to assess
acceptability and identify potential risks.
Execute regulatory strategies by leading the development, authoring
and review of CMC submission components and documentation to support
post-approval supplements/variations, annual reports, registration renewals and
responses to health authority questions per established business processes and
systems.
Liaise with global CMC, Our Manufacturing Division and external
partners to support compliant execution of change management and conduct all
activities with an unwavering focus on regulatory conformance.
Assess and communicate potential regulatory risks and propose
mitigation strategies.
Deliver all regulatory milestones for assigned products across the
product lifecycle
Identify and communicate potential regulatory issues to GRACS CMC
management, as needed
Technical Skills:
Experience in reviewing scientific information to assess technical
merits and suitability of scientific rationale to ensure information is
presented clearly and conclusions are adequately supported by data.
Demonstrated oral and written communication skills and the ability
to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., pharmaceutical
manufacturing, analytical testing, and quality assurance).
Proficient computer skills and previously demonstrated ability to
operate in electronic document based GMP systems
Leadership Skills:
Demonstrated ability to generate innovative solutions to problems
and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or
dealing with unexpected events.
Capability to handle multiple priorities and balance work to achieve
business goals.
Demonstrated effective leadership, communication, and interpersonal
skills
Qualifications &
Skills
Bachelor’s in Science, Engineering, or a related field (advanced
degree preferred). Fields of study
include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology,
Molecular Biology, or Biochemistry
Minimum 5 – 7 yrs of Industry Pharmaceutical industry experience out of 4 years’ experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics The candidate may be required to travel to other CMO sites on a need basis.
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