商丘招聘

Key areas of responsibility:
-Regulatory Planning
-Submissions and Approvals for new products, license renewal, variation, deregistration, etc.
-Regional Regulatory Affairs
-Regulatory Compliance & System
-Cross Functions/Departments Supporting
-Regulatory Influence
-Main job tasks:

1. Regulatory Planning
a)-Regulatory Plan Development
i)Review IP (product implementation plan) and input comments for BAC
ii)To develop China registration plan.

2. Submissions and Approvals for New Products, license renewal, variation, deregistration, etc.
a)Dossier Preparation/Submission
i)Prepare sufficient and quality regulatory dossier and be able to catch up planned submission timeline.
ii)Archive submission documentation and related material

b)Drug test
i)Order, deliver and submit drug samples, reference substance and equipment timely;
ii)Proactively communicate with and respond to the technicians of drug control institutes before and during the drug test to make the process smoothly;
iii)Follow up and manage to push the COA and/or specification to be delivered to the Center of Drug Evaluation (CDE) timely.

c)Gain Regulatory Approval
i)Follow up the evaluation procedure and obtain the license independently
ii)Provide quality and correct response to HA
iii)Communicate with HQ, the related functions within BAC and NNTP to ensure the planned launch feasible

d)Maintain drug license validity.

e)Maintain local marketed products in compliance with local and corporate regulatory requirements and manage to meet target of NN internal principle.

f)Perform regulatory related responsibilities on packaging development. Ensure labelling update timely and correctly.

g)Communicate timely with HQ, the related functional members within BAC and NNTP to ensure the product supply. Support the following pricing, reimbursement and bidding efficiently and timely.

3. Regional Regulatory Affairs
a)Provide professional support to Hong Kong and Tai Wan regulatory affairs
i.Affiliate Hong Kong and Tai Wan on reviewing regulatory plan
ii.Order certificates
iii.Support Hong Kong colleagues on preparing submission dossier, labelling, etc.
iv.Rims maintains

4. Regulatory Compliance and System
a)Regulatory Compliance
i.Accept corporate compliance audit to identify potential compliance issues;
ii.Take corrective actions plans based on regulatory audit findings;
iii.Develop, update and implement appropriate SOPs.

b)Regulatory Tools
i.Be aware of the competitor information and update Competitor Information (CI) database regularly.
ii.Skilled performance in using global regulatory system: RIMS, LOLA, etc.

5. Cross Functions/Departments Supporting
a)Technically supports for HE, GA and COM with regulatory expertise and insight.

b)Provide regulatory support for local manufactured products

c)Provide regulatory support for local clinical trials (i.e. gain CT approval; CT material labelling, CT license, etc…)

6. Regulatory Influence
External
a)Regulatory Customer Relations
Establish good partnership with key regulatory officials.

b)Regulatory Environment Changes
Keep updated with local regulations and technique guidance.

Internal
a)Affiliate Organization
Be familiar with local and global organizations and functions

b)Regulatory Value
Impact on internal customers with regulatory intelligence and share information with RA member. Help establish better system management and routine working process.

Qualifications:
(minimum requirements)
a)Good understanding of the Chinese and global regulations
b)Aiming to achieve positive outcomes in accordance with regulatory regulations and internal SOP
c)Good team working;
d)Good oral/written communication & interpersonal skills
e)Ability to handle conflict; initiative and negotiation skills
f)Work under pressure, creative thinking and problem solving.
g)Skill of communication with internal customers
h)Analytical skills: accuracy, reliability.

Education:
Relevant graduate level degree, e.g. Pharmacy, Pharmacology, Biology.
Fluency in both written & spoken English.

Professional experience:
Min 1 years experience in pharmaceutical industry or related industry like medical devices or healthcare industry
More than 1 year working experience in regulatory affairs or medical department and working experience on international pharmaceutical company is preferred

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