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Chief Manager - Regulatory Affairs - Peptide
Piramal Pharma
posted 4d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Job Overview
A Regulatory Affairs (RA) Head is responsible in ensuring the company s peptide products comply with all relevant regulations. This position involves strategic oversight, regulatory submissions, compliance management, and liaison with regulatory authorities.
Key Stakeholders: Internal
Senior Management at Site, Other departments at Site( Operations, OE, PM, Quality, Supply Chain etc.), Corporate functions(BD).
Key Stakeholders: External
Auditors and Customers on need basis
Reporting Structure
Matrix relationship to site head
Experience
M.Sc/PhD in Chemistry, Biochemistry, Pharmaceutical Chemistry or any related field.
Competencies
- Leadership skills
- Ability to connect the dots in various situations, seeing the risk and keep the mitigation plans.
- Clear communication.
- Analytical mindset.
- Quick and effective decision making.
- Stakeholder management
Key Responsibilities
- Planning and execution of RA activities.
- Managing and coordinating the continuous development and implementation of the regulatory departments strategy, to ensure it meets the business requirements and customer deliverables, as well ensuring the departmental performance against goals.
- Review of regulatory submission US, Europe , Canada & other regions.
- Response to queries from Regulatory agencies and Customers
- Evaluation of changes in pharmacopoeias with respect to API s manufactured and making necessary changes/ inclusion in related documents.
- Review of Pre-approval/ approval of change control, deviation and necessary QMS documents.
- Interaction with cross functional team members of Business development, QC, QA, Production and R&D on various commercial/technical issues required for completion of documents and responding to queries.
- Involvement in various day to day RA activities to implement up to date knowledge regarding guidelines and regulations through training.
Employment Type: Full Time, Permanent
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Company Website
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31%
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8%
3%
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What people at Piramal Pharma are saying
Rating based on 1 Regulatory Affairs Manager
review
Anonymous · Corporate Affairs
in Mumbai, Maharashtra
Likes
Overall culture and policies
Dislikes
None
Read 1 reviewRegulatory Affairs Manager salary at Piramal Pharma
reported by
2
employees
with 15
years exp.
₹15.3
L/yr - ₹19.5
L/yr
At
par with the average Regulatory Affairs Manager Salary in India
View more details
What Piramal Pharma employees are saying about work life
based on 846 employees
Flexible timing
Monday to Saturday
No travel
Day Shift
Piramal Pharma Benefits
Submitted by Company
Free Transport Soft Skill Training Job Training Health Insurance
Submitted by Employees
View more benefits 
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Piramal Pharma Mumbai Office Location
Mumbai, Maharashtra Office
Headquarter
Kamani Junction, LBS Marg, Piramal Ananta, Agastya Corporate Park, Kurla, Maharashtra 400070, IN
Mumbai, Maharashtra
400070
400070
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