Share this Job

Regulatory Affairs Specialist--Beijing

Your role:

  1. Support RA manager to handle daily work.
  2. Provide regulatory expertise to make sure BU business in compliance with local regulation requirements.
  3. Conduct RA role in compliance with company policy and SOP.
    Global Responsibilities
  • Support RA manager to update Allergopharma RA on significant changes of regulations or new regulations issued by the regulatory authorities.
  • Support RA manager to analyze impact of regulatory environment change on BU business and propose actions which Allergopharma RA needs to take.
    Local Responsibilities
  • Fulfill RA responsibility for BU business.
  • Support RA manager to develop and implement registration strategy and plan for new products in align with BU growth strategy.
  • Ensure validation of existing products in terms of license, variation, labeling and packaging without impact on BU business in a timely manner.
  • Keep a good communication with the regulatory authorities to ensure any regulatory application of BU to obtain an optimal results and timely feedback on the request from regulatory authorities.
  • Fulfill process & infrastructure for documentation, dossier preparation and information provided to regulatory authorities as request.
  • As RA role, contribute to the company systems development such as SOPs, working procedures etc. to ensure operational efficiency.
     
    Who you are:
    EDUCATION/LANGUAGES
  • Degree in Life Science or related discipline and a higher degree (PhD, Master).
  • Fluency in English.
    PROFESSIONAL & TECHNICAL SKILLS
  • Minimum of 2 years’ regulatory experience in the pharmaceutical or biotech industry.
  • Excellent understanding of local regulations, guidelines and requirements.
  • Proven expertise in preparing or managing regulatory submissions and achieving approvals.
  • Demonstrated experience in interaction with regulatory authorities.

 

HR95601

Functional area: Regulatory & Medical affairs

Job Requisition ID:  192324
Location:  Beijing - all
Career Level:  A - Current Student
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Biotech, Medical, Pharmaceutical, Biology, Science, Healthcare

Apply now »