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Regulatory Affairs Manager LATAM

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Sao Paulo, Brazil
Human Resources, English, Spanish

Job Description:

Your role:

As a Regulatory Affairs Manager LATAM you will be dedicated to support one of our Life Science Division, being responsible for RA activities of assigned portfolio products, planning and executing regulatory activities supporting the implementation portfolio expansion, working in collaboration with global/ regional functions and stakeholders across the region and the globe providing strategic and functional inputs to the LATAM team.

You will be responsible for:

* Interfaces cross-functionally within RA, as well as with Commercial, Global Marketing, etc. to identify what LATAM requirements will impact the strategy and how to best move forward to meet project plans focused in Bioprocess, Novel therapy, Vaccines, API and Excipients;

* Provide LATAM regulatory intelligence to product teams;

* Responsible for LATAM strategic input for assigned products supporting the expansion of portfolio;

* Interface and Communications with Regulatory Authorities to facilitate productive dialogue on assigned products and detect regulatory trends and influence positively regulatory discussions;

* Regulatory surveillance not only for regulations that impact the company, but also for regulations that impact our customers for communication purposes;

* Support with customer guidance, including presence at customer meetings and/or events for customers;

* Provide Training sessions to support the commercial team understand the regulatory environment, improving their interactions with customers;

* Support to develop procedures to address local regulatory needs that are not covered by global procedures (Bioprocess, DMF requirements for the region, leachable and extractables discussions, food additives requirements, Biodiversity regulations);

* Provide expert advice to ensure proper evaluation of regulations applicable to products and services provided or under development for the company;

* Answers costumer's questions for products portfolio received through our customer services department;

* Support the launch of products, offering a regulatory assessment for the commercial team in region;

Who you are:

A team worker with the ability to influence in order to achieve objectives. You will have excellent organizational skills, flexibility and attention to detail along with a mind-set towards adherence to timelines.

To enable success in this position you will have:

* A degree in pharmacy/life sciences or similar;

* Direct experience in LATAM markets Regulatory Affairs;

* Experience of interactions with Regulatory Authorities;

* Proven knowledge to provide strategic regulatory guidance on Bioprocess, Vaccine and Life Science;

* Demonstratable leadership skills and strong problem-solving abilities, negotiation and communication skills;

* The ability to work independently and function well in a team-oriented environment;

* Ability to communicate clearly both verbally and in writing;

* Excellent negotiation and diplomacy skills;

* Experience in communicating with customers, suppliers, other departments, and senior management on complex issues;

* Excellent organizational and presentation skill;

* Fluent in English and Spanish.

Job Requisition ID: 2xxxx2

Location: São Paulo - all

Career Level: D - Professional (4-9 years)

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 8xx xxx xxx8 from 8:00am to 5:30pm ET Monday through Friday

Source: Company website
Posted on: 21 Feb 2020
Job duration: 0 months
Languages: English, Spanish
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