Expert, Pharm Regulatory Advocacy
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 drugs/biopharmaceuticals, including IND/NDA process, GMP and relevant regulations. In addition, the candidate must be well-versed 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.
Job Requisition ID: 208118
Career Level: E - Professional (10+ years)
Working time model: full-time
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.
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