Consultant-CMC

Work with global clients on regulatory filing projects for the US EU UK China APAC
Canada etc. The key delivery areas include Pre and Post approval CMC authoring
preparation and submission
Scientific writing review and compilation of submission documents such as quality
overall summary (module 2) CMC quality drug product drug substance and regional
information (module 3)
Independently author and/or coordinate CMC activities for new registrations post
approval changes (minor moderate and major) renewals annual reports and line
extensions to meet filing requirements. Coordinating and contributing to responses to
Agency queries and performing quality review of regulatory CMC submissions
Deliver projects in either pharmaceutical / consumer products / Over the counter (OTC)
drug products as per client portfolio/requirements
Ensure timely delivery of errorfree highquality CMC documents that meet
international standards of written English and relevant technical requirements following
internal/clientspecific style guides/templates
Demonstrate expertise at planning CMC submissions including appropriate knowledge
management tools .

Participate in meetings with Client on a regular basis to understand the clients
requirement and proactively support the team in meeting or exceeding the targets in
terms of quality and quantity within the agreed timelines
Demonstrate indepth 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 crossfunctionally 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

Skills and general profile
Good understanding of global regulations USFDA EMA MHRA APAC TGA etc.
North America experience in ANDA NDA IND and basic CMC Life Cycle Management
supplements as well as Canadian filings.
EU experience in initial filing and life cycle management (Type 1A Type 1A/1N Type 1B
and Type II variations).
Knowledge of US and Canadian regulations will be required.
Strong working knowledge of electronic document and submission standards
Excellent communication skills and effective in a collaborative team environment
Advanced skills in the use of MS Word Adobe Acrobat Documentum systems
Effective interpersonal skills
Strong verbal and written English skills
Ability to work in a fastpaced cohesive collaborative teamoriented work
Environment
Commitment to highest quality outputs including meticulous attention to detail

Job Description

Enthusiasm and proactivity
Education
M.Pharm/PhD or equivalent higher degree in a relevant discipline (preferably
Regulatory affairs Pharmaceutics QA Industrial Pharmacy Life Sciences)

Work Experience
Minimum 610 years of regulatory affairs/operations experience in the relevant area
(e.g. Pharma Consumer Medical device)