Expert Pharm Regulatory Advocacy
Expert Pharm Regulatory Advocacy
Posted on :
05-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Your role:
The candidate will be a key regulatory expert for the portfolio of Life Science upstream downstream and raw materials for the biopharmaceutical industry. The candidate should have an understanding of regulatory & quality for sterile /biopharmaceuticals including IND/NDA process GMP and relevant regulations. In addition the candidate must be wellversed in regulatory trends relevant to Life Science products.
- Take active role to build regulatory intelligence for Life Science. Focused area includes Upstream downstream process raw materials management and new technology such as continuous manufacturing.
- Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of business interests.
- Safeguard LS strategic interests and objectives in arising guidance standards and regulation.
- Monitor and report on changes of relevant regulatory and compliance environment with impact with Life Science business. Analyze available regulatory and compliance information.
- Increases the influence of important regulatory bodies and industry associations.
- Secure flow of information from/to authorities industry associations.
- Builds and keeps personal relationships to local and national authorities.
- Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines regulations and standards.
- Training for and support of internal stakeholders external customers and relevant regulatory bodies.
- Builds processes for the flow of information and regulatory intelligence within India.
- Definition of processes to implement upcoming regulatory needs and requirements.
- Support regulatory & quality expertise and consultation for customer regulatory inquiries. Develop the strategy and provide guidance to customers on inspection/audit readiness and drug registration include process validation change control etc.
- Closely work with global regulatory surveillance & advocacy team and Life Science regulatory subject matter experts to link the local advocacy activities with global advocacy activities.
- Monitor competitor approach regarding regulatory requirements.
Who you are:
- Master/Ph.D. Life sciences or related science/engineering background with a strong emphasis in biologics/biopharmaceuticals.
- 6years of relevant industry experience in quality & regulatory related to biopharmaceutical products.
- Proven knowledge of cGMP FDA EMA ISO 9001 standards regulatory and compliance requirements upstream and downstream process.
- Knowledge/experience for regulations concerning complex biologics (i.e. monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture.
- Experience working in a global matrix environment.
- Able and willing to travel.
Employment Type
Full Time
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
