Senior Regulatory Affairs Manager
Share
Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Responsibilities:
- Collaborate closely with global and local teams to develop and implement regulatory strategies for assigned projects including business development initiatives.
- Continuously monitor and analyze the regulatory environment in China as well as major global agencies (FDA EMA PMDA). Translate insights into innovative and actionable regulatory strategy.
- Build strong relationships with internal stakeholders across Regulatory CMC Clinical Operations Medical Quality Business Units Market Access and Commercial teams. Integrate regulatory intelligence and business insights into strategic decision-making. Provide regulatory support for Abbotts planning in business market access commercial activities and quality assessments.
- Represent Abbott in interactions with regulatory authorities industry associations and working groups to support advocacy initiatives aligned with company priorities. Lead and maintain effective communication with regulatory agencies and external consultants.
Supervisory/Management Responsibilities:
Direct Reports: 0-2
Minimum Education:
- A Masters degree or above in pharmacy biology chemistry pharmacology or related life sciences is required
Minimum Experience/Training Required:
- Industry experiences: A minimum of 8 years experience required in Regulatory
- Position experiences:
- Having experience interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies.
- Deep expertise with global regulatory frameworks (NMPA FDA EU/EMA PMDA etc.) .
- Prior experience supporting drug development lifecyclefrom development through submission and post-approval.
- Strong analytical capabilities to assess complex regulatory information and translate it into strategic recommendations.
- Excellent communication presentation and interpersonal skills with the ability to influence without direct authority.
- Experience in Woman Health Gastro Liver CV Urology CNS Vaccine etc. is a plus
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
China > Beijing : Canway Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
