02 Oct
|
CliniLaunch Research Institute
|
Selakui
02 Oct
CliniLaunch Research Institute
Selakui
Hiring – Assistant Manager / Manager – Regulatory Affairs
Location: Selaqui, Dehradun, Uttarakhand
Experience: 7+ Years
Qualification: B.Pharm / M.Pharm / relevant Pharmacy or Life Sciences qualification
CTC: ₹8–14 LPA
We are looking for an experienced Regulatory Affairs qualified to manage regulatory submissions, compliance activities, regulatory intelligence, dossier management, and post-registration activities across targeted international markets.
Key Responsibilities
- Manage regulatory submissions, queries, and submission timelines.
- Track regulatory guidelines, requirements, and changes across target markets.
- Support product registration and post-registration lifecycle activities.
- Manage dossiers, regulatory documentation, and submission-related records.
- Coordinate with Regulatory Authorities, clients, vendors, and internal teams.
- Ensure regulatory requirements are effectively communicated and implemented.
- Identify regulatory risks and coordinate appropriate corrective actions.
- Lead and guide the assigned Regulatory Affairs team.
- Ensure timely completion of regulatory activities and project deliverables.
Key Skills
- Strong knowledge of Pharmaceutical Regulatory Affairs and regulatory processes.
- Experience in regulatory submissions and dossier management.
- Good understanding of regulatory intelligence and compliance requirements.
- Experience handling regulatory queries and post-registration activities.
- Strong documentation, analytical, and problem-solving skills.
- Excellent communication and stakeholder-management skills.
- Ability to manage multiple regulatory projects and timelines.
- Team-handling and leadership experience.
Candidate Profile
- Minimum 7 years of relevant experience in Pharmaceutical Regulatory Affairs.
- B.Pharm / M.Pharm or relevant qualification preferred.
- Minimum 2 years of team-handling experience.
- Experience with multiple international markets will be preferred.
- English and Hindi communication skills are mandatory.
- Candidates willing to work from Selaqui, Dehradun, Uttarakhand are encouraged to apply.
Interested candidates can share their updated CV at:
[email protected]
Pay: ₹700,000.00 - ₹1,500,000.00 per year
Work Location: In person
📌 Regulatory affairs assistant manager (Selakui)
🏢 CliniLaunch Research Institute
📍 Selakui