MANAGER, REGULATORY AFFAIRS-4184140212
Description
MANAGER, REGULATORY AFFAIRS & RISK ASSESSMENT
Janssen PMP
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
Description
The Manager will have regional responsibility for insuring regulatory compliance of Janssen PMP products and services in Asia Pacific (Greater China, AUS/NZ, ASEAN, and Japan). The preferred candidate shall have thorough knowledge and experience in international chemical regulatory affairs (industrial chemicals, pesticides, biocides, food additives) and a scientific/technical background, preferably in chemistry.
RESPONSIBILITIES
- To conceptualize, create and implement the registration approach for PMP products that are developed and marketed in the region.
- To work with the global Business Units to proactively incorporate regulatory intelligence into the strategic planning process.
- Assist the sales and development manager in developing the regional business. Support Janssen PMP distributors and customers in regulatory and technical matters, including chemical import and reporting requirements.
- To prepare the registration dossiers for the PMP products in order to obtain the necessary authorizations for the marketing and sales of the products in the relevant geographic area.
- To establish, develop and maintain relationships with regulatory authorities and perform sponsor monitoring and compliance oversight for studies with contract research organizations.
- Monitor legislation and international developments which may affect the regulatory status and classification of PMP. Provide product compliance guidance.
Qualifications
- An advanced degree and/or industry experience in chemistry is preferred, however degrees/experience in other biological sciences, such as pharmacy, biomedical engineering, toxicology will be considered.
- 3-5 years’ experience within a regulatory affairs department in either the pharmaceutical, veterinary, or agrochemicals/biocides industry.
- An understanding and experience of GxP guidelines, i.e. GLP, GCP and GMP.
- Knowledge and/or experiences in the emerging legislations in countries within the Asia Pacific region for industrial chemicals, biocides/ agricultural chemicals or food additives in industrial, institutional, residential markets and/or cosmetic preservatives.
- An existing network of contacts with the Regulatory Authorities, in key markets in the region, especially, China, South Korea, Philippines, Thailand, and Singapore is preferred.
- A team player in a small independent allied business of Janssen Pharmaceutica NV, requiring multifunctional responsibility and flexibility. Candidate should be an independent worker and self-starter with a holistic, innovative and process driven view on regulatory affairs activities in line with business development.
- Proficient in spoken and written English is essential; fluency in written and verbal communication in Chinese is desirable.
- Willing to travel up to 30% of the time.
LOCATION
This position is to be based in Singapore. No relocation provided.
APPLICATION DEADLINE
7th March 2014
J2W: LI ASPAC
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Regulatory Affairs
Description
MANAGER, REGULATORY AFFAIRS & RISK ASSESSMENT
Janssen PMP
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
Description
The Manager will have regional responsibility for insuring regulatory compliance of Janssen PMP products and services in Asia Pacific (Greater China, AUS/NZ, ASEAN, and Japan). The preferred candidate shall have thorough knowledge and experience in international chemical regulatory affairs (industrial chemicals, pesticides, biocides, food additives) and a scientific/technical background, preferably in chemistry.
RESPONSIBILITIES
- To conceptualize, create and implement the registration approach for PMP products that are developed and marketed in the region.
- To work with the global Business Units to proactively incorporate regulatory intelligence into the strategic planning process.
- Assist the sales and development manager in developing the regional business. Support Janssen PMP distributors and customers in regulatory and technical matters, including chemical import and reporting requirements.
- To prepare the registration dossiers for the PMP products in order to obtain the necessary authorizations for the marketing and sales of the products in the relevant geographic area.
- To establish, develop and maintain relationships with regulatory authorities and perform sponsor monitoring and compliance oversight for studies with contract research organizations.
- Monitor legislation and international developments which may affect the regulatory status and classification of PMP. Provide product compliance guidance.
Qualifications
- An advanced degree and/or industry experience in chemistry is preferred, however degrees/experience in other biological sciences, such as pharmacy, biomedical engineering, toxicology will be considered.
- 3-5 years’ experience within a regulatory affairs department in either the pharmaceutical, veterinary, or agrochemicals/biocides industry.
- An understanding and experience of GxP guidelines, i.e. GLP, GCP and GMP.
- Knowledge and/or experiences in the emerging legislations in countries within the Asia Pacific region for industrial chemicals, biocides/ agricultural chemicals or food additives in industrial, institutional, residential markets and/or cosmetic preservatives.
- An existing network of contacts with the Regulatory Authorities, in key markets in the region, especially, China, South Korea, Philippines, Thailand, and Singapore is preferred.
- A team player in a small independent allied business of Janssen Pharmaceutica NV, requiring multifunctional responsibility and flexibility. Candidate should be an independent worker and self-starter with a holistic, innovative and process driven view on regulatory affairs activities in line with business development.
- Proficient in spoken and written English is essential; fluency in written and verbal communication in Chinese is desirable.
- Willing to travel up to 30% of the time.
LOCATION
This position is to be based in Singapore. No relocation provided.
APPLICATION DEADLINE
7th March 2014
J2W: LI ASPAC
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Regulatory Affairs