Consultant/Senior Consultant, Regulatory CMC (Dossier Readiness):

• 07 positions
• This role is regarding the gap assessment of the CMC dossiers.
• Relevant Experience: Minimum 7 years in CMC
• Salary Range: 8 to 12 LPA

Job Description
Page 1 of 2
Position: Senior Consultant, Regulatory Affairs (Dossier Readiness for LCM)
Job Overview
Responsible for performing gap analysis of the product dossiers by assessing the agency
submissions including but not limited to module 3 sections across dedicated document
management systems. Identifying the gaps i.e. missing information and documents, seeking
appropriate solutions in consultation with appropriate stakeholders, and closing the gaps to
ensure that the baseline product information is up to date for the product life cycle management
activities. The ideal candidate must demonstrate both technical CMC knowledge and document
management skills.
Functional Responsibilities
• Perform a gap assessment of existing document management systems and develop an
action plan in collaboration with the project manager and other stakeholders for
addressing the gaps
• Device strategies to address gaps in documents in agreement with stakeholders ensuring
minimal impact on business (i.e. reducing the need for approvals or unnecessary RA
intervention)
• Write, review, and compile submission documents such as quality overall summary
(module 2), CMC quality – drug product, drug substance and regional information
(module 3)
• Ensure timely delivery of error-free, high-quality CMC documents that meet international
standards of written English and relevant technical requirements following
internal/client-specific style guides/templates
• Participate in meetings with stakeholders on a regular basis to understand the
requirements and proactively support the team in meeting or exceeding the targets in
terms of quality and quantity within the agreed timelines
• Demonstrate in-depth understanding of content requirements, including awareness and
understanding of CTD format and apply expertise to ensure global regulatory
commitment tracking
• Prioritize and complete assigned workload appropriately under minimum supervision
• Proactively identify moderately complex issues and risks to project delivery in own work
or work of the team and escalate appropriately with associated resolution proposals
• Work cross-functionally and in collaboration with key stakeholders/customers both
internal and external
• Ensure that all training (internal training and client training) are successfully completed in
a timely manner
Note: The above statements describe the general nature and level of work to be performed and
are not an exhaustive list of all responsibilities required for the position.
Job Description
Page 2 of 2
Education
B. Pharma/BS Degree, and/or advanced degree in a health or life science-related field
Skills and personal attributes
• Active, continuous demonstration of the CONTINUUM values
• Extensive experience and technical skills within Regulatory Operations
• Ability to directly oversee and lead projects and people in a matrix environment
• Excellent relationship-building, people management and communication skills.
• Ability to communicate independently with overseas LRA colleagues.
• Integrity, credibility, and commitment to building the CONTINUUM brand in the
marketplace
• Demonstrates the ability to use knowledge and experience to understand financial and
industry data to make decisions
Minimum Work Experience
At least 6+ years of regulatory affairs/ CMC experience/eCTD compliance. If the candidate has
the following experience, it would be a plus:
• Thorough understanding of the drug development process for all phases of
pharmaceutical development and applied comprehensive understanding of regulations
and guidelines to enhance the probability of regulatory success and regulatory
compliance.
• Strong problem-solving skills to evaluate technical information and identify appropriate
regulatory actions.
• Proven ability to support multiple project teams, identify and resolve regulatory issues.
• Demonstrated understanding of Global Regulatory Affairs processes, both pre- and postmarketing
is highly preferred.
• Experience in planning and management of global regulatory submissions (e.g. MAA, and
lifecycle documents etc.) is required.
• CMC authoring for products marketed in EU, UK, APAC, LATAM and Africa and basic CMC
Life Cycle Management supplements.
• Experience in working with leading global and/or virtual teams is preferred, especially if
done within a matrix organization.