About the role
Job Title:
Specialist Regulatory Affairs LCM Strategic Growth Products
Hiring Manager:
Shakun Kumar
Grade
P3
Briefing Date:
14-Aug-2026
Department:
Regulatory Affairs
Location (Remote/Office)
Andheri (Hybrid)
VACANCY PROFILE
Discuss profile with the Hiring Manager to gain a comprehensive understanding of the role, and what the candidate should expect if successful:
Description of the department/function (ask for HM to provide a description, which can be used on the internal advert):
Strategic Growth products LCM is a newly created team within Global Regulatory affairs function, which is responsible for the lifecycle maintenance of Marketing Authorizations of Strategic Growth products (complex generics, Innovative products and Biosimilars), across global markets
Description/overview of role (what does a typical day/week/month look like):
Work closely with New Products Introduction team and support timely launch of the products, perform MA maintenance activities such as variations/renewals/PIP modifications, labelling/artwork updates etc. submissions as needed, lead interactions with MAs/Health Authorities; perform change control, impact assessments, etc.
How will success of the role holder be measured:
Up-to-date knowledge of the regulatory requirements and processes, quality and timeliness of submissions
What career development opportunities exist within role/department:
From P3-P4
Team Structure:
6-member team including Shakun
Challenge:
Finding someone with adequate experience in Biosimilars in EU region. Relocation and finding talent within CTC may be difficult as well.
What makes this role attractive/why should a candidate apply:
Mostly other pharma companies have specialised roles restricted to one type of activity/product range. In this role, people will get exposure to complete LCM activities of different types of products for global markets..
CANDIDATE PROFILE
Ascertain the Hiring Manager’s requirements for the candidate’s experience/skills, providing guidance as required:
Ideal Experience:
For Role 1 (Biosimilars)
- 8-10 yrs of exp in entire LCM (EU/UK and other regulated markets) with at least 3-5 yrs of latest proven experience in Biosimilar CMC exp in EU, or hands-on/ Small molecules CMC exp in EU Centralised procedures and LCM exp is a must, and EU biosimilars LCM/new registration would be additional.
- Well-versed with EU/UK Regulatory requirements/processes and ICH requirements
- Good CMC knowledge/skills
- Experience interacting with EU/UK regulatory authorities – Scientific advice meetings/ Pre-submission meetings is desirable
- Good understanding of EU Medical Device Requirements
Minimum Experience considered:
6-10 Yrs
Most Important Thing about the Candidate/their experience:
Integrity, Honesty and being able to explain their Exp in CV
What alternative job titles could this role be called:
Asst. Manager, Manager, specialist RA
What is the target start date for the role:
End of July
SOURCING PROCESS
Discuss the recommended sourcing strategy with Hiring Manager, taking into consideration the following:
What sourcing methods have been effective previously when recruiting this role or similar:
Not aware.
Would the Hiring Manager like to utilise any industry specific websites:
None
Does the Hiring Manager have any candidates within their network, who they would like TA to approach:
None
Which competitor organisations could be a good source of potential candidates:
Alvotech, Enzene, biological E, Biocon, Sanofi, BMS, Novo Nordisk, Dr. Reddy’s, Teva, Novartis (For Innovatives role), Abbott, Pfizer (may have biosimilars), Other pharma MNCs with business model similar to Advanz.
Remind Hiring Manager of Employee Referral programme, and ask for their support in promoting the programme with team members.
If an agency is to be engaged, does the Hiring Manager have a preferred vendor (ideally on PSL – if not, discuss with Head of TA):
SCREENING PROCESS
Provide Hiring Manager with guidance on TA’s recommended candidate screening and interview process, and discuss:
Does the Hiring Manager have any specific questions they would like included in interview screening stage:
Does the Hiring Manager have any target interview dates:
ASAP
What is the Hiring Manager’s preferred interview format? i.e. presentation stage etc
VC with Shakun, F2F with Shakun, HR
Which stakeholders would the Hiring Manager like involved in the interview process, and at what stage: (remind Hiring Manager to request interviewer participation as a courtesy)
CONCLUDE
End the call by thanking the Hiring Manager for their time, and cover off the following:
Agree frequency and method of vacancy updates:
Once in a week
Ask if they are comfortable with the hiring process as a Hiring Manager, or if there are any areas they would like support with:
Remind Hiring Manager of the importance of their responsiveness in order to keep candidate’s engaged and process moving:
Anything else the Hiring Manager would like to add, which hasn’t been discussed:
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