沈阳招聘

Key areas of responsibility:
- Management
- Regulatory Planning and Process Management
- Submissions and Approvals for New Products
- Product Life Cycle Management
- Regional regulatory affairs
- Cross Functions/Departments Supporting
- Regulatory Influence
Main job tasks:

1. Management

a) People Development
i. Manage and coach the Regulatory Affairs Team effectively to achieve successful results and share best practices.
ii. Ensure that each team member has clear job target, developed IDP, and performance review.
iii. Recruit, retain and provide career development opportunities and succession planning for regulatory talent.
iv. Reward and recognize individuals as appropriate for superb achievements.
v. Ensure team member finish related trainings: local regulatory requirement, NN global and local SOPs.

b) Budget Planning and Control
i. Provide accurate budget plan and control for projects and team development
ii. Provide accurate manning plan for team

2. Regulatory Planning and Process Management

a) Regulatory Plan Development
i. As GRT member, review and recommend regulatory strategy for submissions, take HK and TW into account. Communicate with global project team and local MAK for registration strategy.
ii. Review IP (product implementation plan) and recommend regulatory strategy for major variations
iii. Review product license renewal plan and cross departments plan (RA, MAK, COM, GA, NNTP), ensure product supply during license renewal.
iv. Provides resources allocation needs and capabilities during the business planning process to support the business plan and strategies.

b) Process Management
i. Lead the development of an appropriate process co-ordination with other functional members of the affiliate, sites and corporate (Legal, Administration, etc.), to ensure timely availability of required documents/approvals and interrelated processes.
ii. Active participation in cross-functional key teams within the affiliate and ability to influence business strategies to ensure regulatory needs and wants are addressed.
iii. Assign personnel to cross-functional teams and provide regulatory expertise to ensure regulatory timelines are met or improved
iv. Prepare and manage the budget and resources assessment for local business plan of the Regulatory Affairs Department.

c) Regulatory Tools
i. Manage affiliate regulatory data is entered into the RAPT database (Regulatory Activity Planning and Tracking) and Competitor Information (CI) database.
ii. Manage to ensure RAPT and CI data are complete, accurate and regular updates meet or improve upon the established compliance metrics.
iii. Ensure team member as qualified end user of global regulatory system: RIMS, LOLA.

3. Submissions and Approvals for New Products

a) Dossier Preparation/Submission
i. Review final prepared application or responses prior to formal submission to ensure quality, timing and meets local or corporate requirements.
ii. Coaches and advise on all regulatory matters involved in regulatory preparation, submission & approval; and if applicable, pricing activities.

b) Gain Regulatory Approval
i. Negotiate with HA a competitive label and company shelf-life specification.
ii. Negotiates with the HA to gain regulatory advantage and outcomes during the evaluation process (from pre-submission planning until final approval is gained).

c) Metrics Review
i. Manage regulatory performances to meet or improve upon the planned timelines including local manufacturing and clinical trial activities, and recommend actions to improve timelines.
ii. Distribute a periodic Regulatory Report for responsible products (including HK) to summarise the key regulatory activities to ARD (associate regulatory director).

4. Product Life Cycle Management

a) STF updates
i. Manage to maintain local marketed products in compliance with local and corporate regulatory requirements, ensure meet target of NN internal principle (CARL).
ii. Perform Risk assessment and provide appropriate regulatory solutions for compliance issues.
iii. Ensure that corrective actions plans based on regulatory audit findings
iv. Ensure high quality of product labelling preparation and review.

b) Product Discontinue/deregistration
i. Review product launch plan with MAK dept. Finish NN product discontinue/deregistration process in RIMS.

5. Regional Regulatory Affairs
a) Regulatory planning for HK
b) New product and Life cycle management support for HK
c) Dossiers preparation
d) RIMS maintainance
e) Labelling preparation on LOLA
f) Communication between HK and HQ

6. Cross Functions/Departments Supporting
a) Technically supports with HE, GA and COM for Drug Regulatory Agency price negotiations.
b) Provide quality regulatory support for locally manufactured products
c) Provide regulatory support for locally performed clinical trials (i.e. gain CT approval; CT material labelling, CT licence, etc…)

7. Regulatory Influence

External

b) Regulatory Customer Relations
i. Build and maintain relationships with key regulatory officials.

c) Regulatory Environment Changes
i. Keep updated with current local regulations and RA organisational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties.

d) Influence Strategy
i. Develop and implement the external regulatory influence strategy.

Internal

a) Affiliate Organisation
i. Learn and understand the local affiliate organisation and functions.
ii. Build functional partnership and credibility to maximize regulatory value in support of business decisions.
iii. Recognized and a valued member of affiliate decision making process that has or potentially has regulatory involvement.

Qualifications:
(minimum requirements)
a) In-depth knowledge of local regulations pertaining to pharmaceutical products and devices
b) Leadership, strategic planning and visionary
c) Good people management skills, capable to give positive influence and motivation to team members
d) Ability to handle multi-task activities; Proactive and creative thinking and problem shooting
e) Skill of communication with internal customers
f) Effective communication and argument with HA

Education:
- Relevant graduate level degree, e.g. Pharmacy, Pharmacology, Biology.
- Fluency in both written & spoken English.
Professional experience:
- Min 5 years experience in pharmaceutical industry or related industry like medical devices or healthcare industry
- Strong leadership and people management skill

Professional experience:
- Min 5 years experience in pharmaceutical industry or related industry like medical devices or healthcare industry
- Strong leadership and people management skillProfessional experience:
- Min 5 years experience in pharmaceutical industry or related industry like medical devices or healthcare industry
- Strong leadership and people management skill

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