Assistant Regulatory Affairs Manager
上海艾玛企业管理有限公司
- 公司规模：少于50人
- 公司行业：制药/生物工程
职位信息
- 发布日期：2013-05-13
- 工作地点：北京
- 招聘人数：若干
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语精通
- 职位类别：政府事务管理 法务主管/专员
职位描述
Purpose of the Job
Manage Compliance & External Environment in the area of Regulatory Affairs for IFT, IFT-ingredients, Food, and Food-ingredients. Advisory role to the RFC IFT Governance Board.
l Ensure regulatory compliance for IFT-ingredients (B2B), IFT- final (B2B);
l Influence the regulatory environment in China;
l Build & maintain Regulatory relationship with Gov & experts;
l Build RA knowledge and competence within RFC RA
Business Context and Complexity
l IFT category is characterized by competition from global pharmaceutical multinationals (like Pfizer and Abbott) or food majors (like Nestle and Danone). On top of this competition, the industry faces stringent international and local legislative environment, which remains highly volatile. In the B2B IFT environment the extra dimension regarding regulatory affairs lies in the significant liabilities between BGI and its customers both trying to minimize exposure. Fulfilling our ambitious growth plans will simply not be possible without managing these forces successfully. The nature of responsibilities under Regulatory Affairs is such that the associated competencies will necessarily have to be made available in-house - outsourcing is not an option.
l Successful management of the Regulatory Environment will also be a key success factor for the other growth platform in CPI - Everyday Family Nutrition.
l The position accumulates the associated knowledge and competencies and delivers them in the form of directions to our operating companies and influence on the external environment beneficial to RFC in general and CPI in particular.
Result Areas
l Ensure regulatory compliance for China project
a. Review and ensure compliance of the Spec, Formulas, Labels, Off-pack materials for Infant
& children formula, ingredients, cheese & butter, etc;
b. Provide assessment & advice for IFT & dairy related new Regulations to business team to
ensure proper and timely implementation of new legislation;
c. Provide regulatory assessment of new ingredients and advise on product claims
d. co-ordinate submission of petition dossiers to regulatory authorities
l Influence the regulatory environment in China
a. Facilitate approval of innovations (eg registrations) in PRC
b. Identify at an early stage in the development of new or amended legislation where
anticipation is needed
c. Develop local positions on the desired outcome
d. Determine lobbying at the local level to influence proposed legislation in line with company
objectives
l Build & maintain Regulatory relationship with Government, experts, and scientific bodies:
a. Build and maintain good relationships with authorities and NGO;
b. Extend existing good relationships that are developed in specific area's (such as infant
nutrition): government, industry, NGOs.
c. Take an active role in national trade association activities and communicate specific business
objectives to all relevant FrieslandCampina employees.
d. Strengthening and leading local lobby
l Build RA knowledge and competence within RFC RA
a. Create internal network within the different Opco's
b. Align with relevant Dept. to create internal local process/SOP;
c. Build & Maintain Chinese regulation Database and share with CPI/Ingredient/Cooperate
team;
l Issue/Crisis management
a. Provide regulatory support for negative exposure/ consumer complaints of Friesland
Campina;
b. Provide regulatory support in case of problems work with national food agencies and other
controlling agencies towards an acceptable solution
Personality Profile
l Should be able to deal with a multicultural environment - sensitive, yet firm
l Should be able to manage high work pressure (crisis situations) and be able to operate within tight deadlines
l Should have a systematic way of working and thinking.
l Should be capable of representing FC interests in Industry bodies. Typically peer group would comprise senior managers from competitive organizations. This critical role will ensure that impact of current and future legislation on our market plans is controlled and limited
l Should be capable of convincingly communicating and defending FC interests with pressure groups This role is essential to manage the clear conflict of interest between these bodies and FC's commercial interests. Failure here will severely curtail our activity plans with direct impact on our business results.
Knowledge
Behavioral:
l Persuasiveness at level 3
l Vision, Decisiveness, Creativity, Entrepreneurship, and Leadership & Teamwork at level 2-3
Generic:
l Project Management, English, Customer Services, and Functional Training at level 3-4
l Performance management, Third Party Management, Budget & Cost Control at level 2-3
l Quality management System at level 4
Functional:
l Regulation Knowledge - level 3-4
l Manufacture Process Knowledge - level 3-4
l Ingredient Knowledge - level 2-3
l Lobbying and Networking Abilities within Technical Area - level 3-4
Skills
Interactive Skills
l Communicate with several (levels of) functions
l Negotiate with competitors and authorities
l Give presentations to a wide audience
l Propose regulatory options in developing marketing strategy
l Speak fluently Mandarin, English
l Translate near native between Mandarin and English
l Deal with a multicultural environment
Qualifications & Experience
l Academic education (Agriculture, Food, or Nutrition) (Ph.D & Master preferred.)
l Minimum 3 years work experience in a comparable position and environment
l Proven ability to manage, participate in complex projects with a multidisciplinary team in an international environment
Manage Compliance & External Environment in the area of Regulatory Affairs for IFT, IFT-ingredients, Food, and Food-ingredients. Advisory role to the RFC IFT Governance Board.
l Ensure regulatory compliance for IFT-ingredients (B2B), IFT- final (B2B);
l Influence the regulatory environment in China;
l Build & maintain Regulatory relationship with Gov & experts;
l Build RA knowledge and competence within RFC RA
Business Context and Complexity
l IFT category is characterized by competition from global pharmaceutical multinationals (like Pfizer and Abbott) or food majors (like Nestle and Danone). On top of this competition, the industry faces stringent international and local legislative environment, which remains highly volatile. In the B2B IFT environment the extra dimension regarding regulatory affairs lies in the significant liabilities between BGI and its customers both trying to minimize exposure. Fulfilling our ambitious growth plans will simply not be possible without managing these forces successfully. The nature of responsibilities under Regulatory Affairs is such that the associated competencies will necessarily have to be made available in-house - outsourcing is not an option.
l Successful management of the Regulatory Environment will also be a key success factor for the other growth platform in CPI - Everyday Family Nutrition.
l The position accumulates the associated knowledge and competencies and delivers them in the form of directions to our operating companies and influence on the external environment beneficial to RFC in general and CPI in particular.
Result Areas
l Ensure regulatory compliance for China project
a. Review and ensure compliance of the Spec, Formulas, Labels, Off-pack materials for Infant
& children formula, ingredients, cheese & butter, etc;
b. Provide assessment & advice for IFT & dairy related new Regulations to business team to
ensure proper and timely implementation of new legislation;
c. Provide regulatory assessment of new ingredients and advise on product claims
d. co-ordinate submission of petition dossiers to regulatory authorities
l Influence the regulatory environment in China
a. Facilitate approval of innovations (eg registrations) in PRC
b. Identify at an early stage in the development of new or amended legislation where
anticipation is needed
c. Develop local positions on the desired outcome
d. Determine lobbying at the local level to influence proposed legislation in line with company
objectives
l Build & maintain Regulatory relationship with Government, experts, and scientific bodies:
a. Build and maintain good relationships with authorities and NGO;
b. Extend existing good relationships that are developed in specific area's (such as infant
nutrition): government, industry, NGOs.
c. Take an active role in national trade association activities and communicate specific business
objectives to all relevant FrieslandCampina employees.
d. Strengthening and leading local lobby
l Build RA knowledge and competence within RFC RA
a. Create internal network within the different Opco's
b. Align with relevant Dept. to create internal local process/SOP;
c. Build & Maintain Chinese regulation Database and share with CPI/Ingredient/Cooperate
team;
l Issue/Crisis management
a. Provide regulatory support for negative exposure/ consumer complaints of Friesland
Campina;
b. Provide regulatory support in case of problems work with national food agencies and other
controlling agencies towards an acceptable solution
Personality Profile
l Should be able to deal with a multicultural environment - sensitive, yet firm
l Should be able to manage high work pressure (crisis situations) and be able to operate within tight deadlines
l Should have a systematic way of working and thinking.
l Should be capable of representing FC interests in Industry bodies. Typically peer group would comprise senior managers from competitive organizations. This critical role will ensure that impact of current and future legislation on our market plans is controlled and limited
l Should be capable of convincingly communicating and defending FC interests with pressure groups This role is essential to manage the clear conflict of interest between these bodies and FC's commercial interests. Failure here will severely curtail our activity plans with direct impact on our business results.
Knowledge
Behavioral:
l Persuasiveness at level 3
l Vision, Decisiveness, Creativity, Entrepreneurship, and Leadership & Teamwork at level 2-3
Generic:
l Project Management, English, Customer Services, and Functional Training at level 3-4
l Performance management, Third Party Management, Budget & Cost Control at level 2-3
l Quality management System at level 4
Functional:
l Regulation Knowledge - level 3-4
l Manufacture Process Knowledge - level 3-4
l Ingredient Knowledge - level 2-3
l Lobbying and Networking Abilities within Technical Area - level 3-4
Skills
Interactive Skills
l Communicate with several (levels of) functions
l Negotiate with competitors and authorities
l Give presentations to a wide audience
l Propose regulatory options in developing marketing strategy
l Speak fluently Mandarin, English
l Translate near native between Mandarin and English
l Deal with a multicultural environment
Qualifications & Experience
l Academic education (Agriculture, Food, or Nutrition) (Ph.D & Master preferred.)
l Minimum 3 years work experience in a comparable position and environment
l Proven ability to manage, participate in complex projects with a multidisciplinary team in an international environment
公司介绍
Emmahr was founded in 2002. Based in Shanghai, Emmahr is a professional HR Services Provider who offers both enterprises and individuals professional and responsible HR solutions throughout China.
We focus on recruiting top-level management and technical talents in specialized
industries, such as FMCG,financial, manufacturing, automotive, information technology, etc.
Our consultants are not only experts in the local Human Resources market and job profiles, but also have a great understanding of the business areas that they serve.
We follow our recruiting guidelines and processes very strictly for every single recruiting assignment to ensure a highly qualified outcome. Emmahr is dedicated to finding the right person for the right job.
It is our goal to help your business efficiently withstand the ever-changing business environment.
注：将您的简历用电子邮件发至本公司，在主题标明申请职位，并将简历粘贴于电子邮件之内。
We focus on recruiting top-level management and technical talents in specialized
industries, such as FMCG,financial, manufacturing, automotive, information technology, etc.
Our consultants are not only experts in the local Human Resources market and job profiles, but also have a great understanding of the business areas that they serve.
We follow our recruiting guidelines and processes very strictly for every single recruiting assignment to ensure a highly qualified outcome. Emmahr is dedicated to finding the right person for the right job.
It is our goal to help your business efficiently withstand the ever-changing business environment.
注：将您的简历用电子邮件发至本公司，在主题标明申请职位，并将简历粘贴于电子邮件之内。
联系方式
- 公司地址：地址：span新桥开发区