Reg Affairs CMC Director - United Kingdom
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The EU/EEMEA Vaccines Regulatory CMC Senior Strategist will be responsible to lead strategy development and execution of European region (EU/EEMEA) CMC life-cycle submissions and new product registrations for company Vaccines products. It will ensure a focus on local needs of EU/EEMEA Country Regulatory Affairs (RA) teams and the needs of HQ CMC teams for these products.
- The position will be part of the company International CMC EU/EEMEA Regional hub.
- The International CMC Regional Hub is a key component of company’s strategy to build regional CMC regulatory knowledge and effective local relationships with company country RA offices, in order to deliver appropriate regulatory strategies, deliver right first time regulatory submissions, and support ongoing conformance of company’s manufacturing practices with the registered product details.
- For EU/EEMEA Vaccines, the Senior Strategist will have primary responsibility to develop robust and well-planned CMC regulatory strategies for the management of post-approval technical changes and for the initial EU registration of new company Vaccines.
- In coordination with global CMC Regulatory leaders, the Senior Strategist will develop and execute regulatory strategy for Vaccine product lifecycle submissions in the EU/EEMEA regional markets, for management of CMC changes originating at manufacturing sites or affiliates, by maximizing submission efficiency and quality to ensure right first time and a high rate of submission approvals by Health Authorities.
- The Senior Strategist will be the primary regulatory (CMC) point of contact for the Regional/Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the HQ CMC product leaders and all parts of the company Regulatory network.
- Act as subject matter expert in EU/EEMEA Vaccine product CMC regulatory requirements post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility. Communicate proactively with HQ CMC staff on Vaccines registration requirements.
- For EU/EEMEA Vaccines products, participate and influence the CMC strategy by engagement with industry forums and BoH to pursue high priority advocacy plans.
- Drive continuous improvement activities within organization and excellent partnership within company wide CMC and international partners to ensure efficient processes and best practices.
- Support the company’s Product Conformance of all products in the region by ensuring local registrations and lifecycle management align with product manufacturing details.
- Ensure timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.
- Coordinate strategic planning with Regional Supply Chain and Affiliate DRAs for change management alignment and early visibility/communication/planning of changes impacting markets in the region.
- Manage tracking of Health Authority commitments as result of license/dossier approval and ensure commitment due dates are met.
- Ensure timely update of the CMC change management electronic systems, using the regulatory information provided from the submission/approval externally by a Health Authority, or internally by the appropriate functional area.
- Upon request, support country DRA interactions with regulatory authorities to facilitate the prompt review and approval of submissions (as CMC content Subject Matter Expert).
- The candidate may be required to travel to other company sites on a periodic basis.
- BSc. in a biological science, engineering, or a related field (or equivalent) (advanced degree preferred).
- Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
- At least 7 years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or licensure of biological products; or related fields.
- The candidate will have strong experience in Regulatory Affairs for the EU/EEMEA regional markets, with a focus on CMC requirements for Vaccines or Biologic products, development, manufacturing and/or quality assurance.
- Must have a proven ability to communicate effectively in both a written and verbal format.
- The candidate must be proficient in English; additional language skills are a plus.
- Ability to influence and work both independently and collaboratively in a team structure.
- Proven ability to work well under pressure
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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