Hetero Labs Ltd. are inviting applications from experienced professionals for their Regulatory Affairs – Formulations department.
The company is looking for people to manage regulatory submissions in the emerging markets (Asia, the Middle East and the CIS).
This is an opportunity for experienced pharma people with a strong background in CTD/eCTD dossier preparation, product registrations and regulatory conformance.
Eligible candidates with 10-15 years of relevant experience can apply for Manager and Senior Manager posts in Hyderabad, Telangana.
The company is looking for people to manage regulatory submissions in the emerging markets (Asia, the Middle East and the CIS).
This is an opportunity for experienced pharma people with a strong background in CTD/eCTD dossier preparation, product registrations and regulatory conformance.
Eligible candidates with 10-15 years of relevant experience can apply for Manager and Senior Manager posts in Hyderabad, Telangana.
Company Overview
Hetero Labs Ltd. is a pharma company that develops and manufactures pharmaceuticals. They’re currently expanding their Regulatory Affairs – Formulations team to support product registrations and regulatory activities in a number of emerging international markets.
Job Details – Hetero Labs Ltd. Recruitment
| Company Name | Hetero Labs Ltd. |
| Department | Regulatory Affairs – Formulations |
| Designation | Manager / Senior Manager |
| Experience | 10–15 Years |
| Job Location | Hyderabad, Telangana |
| Market Coverage | Asia, Middle East and CIS Countries |
| Industry | Pharmaceutical |
| Application Mode |
Job Openings – Regulatory Affairs (Formulations)
Manager / Senior Manager – Regulatory Affairs
Department: Regulatory Affairs – Formulations (Emerging Markets)
Experience: 10–15 Years
Location: Hyderabad, Telangana
Market coverage: the emerging markets (Asia, the Middle East and the CIS countries).
Job Role & Responsibilities
Selected candidates will be responsible for managing the regulatory submissions, product registrations and compliance activities in the various emerging international markets.
Regulatory Dossier Preparation & Submission
- Lead the preparation, compilation, review and filing of the CTD/eCTD and country specific regulatory dossiers.
- Manage new product registrations and variations for pharma formulations in the emerging markets.
- Ensure compliance with the relevant country specific regulatory guidelines and submission requirements.
- Develop the regulatory strategy for new product launches into the target international markets.
- Assess the regulatory routes, the documentation requirements and the registration times.
Regulatory Strategy & Market Growth
- Identify regulatory opportunities and enable business growth into new markets.
- Coordinate the regulatory activities to support the product launches in the various international markets.
- Keep a close eye on any changes to the regulatory guidelines and the country specific registration requirements.
- Guarantee compliance with the applicable WHO, ICH and local regulatory requirements as relevant.
Post-Approval Changes & Product Lifecycle Management
- Manage post-approval changes including changes to the manufacturing site, formulation, specifications, analytical methods, packaging and other regulatory changes.
- Guarantee that regulatory variations are submitted and approved in a timely manner.
- Keep regulatory compliance in place right through the product lifecycle.
Regulatory Coordination & Documentation
- Co-ordinate with the international regulatory authorities, consultants, distributors and local reps.
- Respond to any queries or deficiency letters received from the regulators.
- Check pending applications and ensure that product approvals are actioned promptly.
- Coordinate with Formulation R&D, Analytical R&D, QA, QC, Production, Packaging Development and all other relevant departments.
- Secure timely collection and review of the technical documents required for regulatory submissions.
- Support technology transfers, new product development and scale-up from a regulatory perspective.
Eligibility & Qualifications
Candidates with a relevant pharmaceutical and life sciences educational background and significant experience in regulatory affairs for pharmaceutical formulations can be considered.
Relevant Educational Qualifications:
B.Pharm | M.Pharm | Pharm.D | M.Sc. Pharmaceutical Chemistry | M.Sc. Chemistry
The above are the suggested qualifications for the Regulatory Affairs – Formulations role. The recruitment ad doesn’t actually list the employer confirmed qualifications.
Experience Requirements
- 10 to 15 years of relevant professional experience.
- Experience in Regulatory Affairs (Formulations)
- Knowledge of CTD/eCTD dossier preparation and filing.
- Experience in product registrations and the various regulatory changes that occur in the emerging markets.
- Understanding of the country specific regulatory requirements and the international pharmaceutical regulations.
How to Apply for Hetero Labs RecruitmenInterested and eligible candidates are invited to submit their updated profiles via the recruitment email address provided below.ow.
Send Your Resume To:
Email: Vijayakiran.ch@hetero.coCandidates with relevant experience in Regulatory Affairs (Formulations and in the emerging international markets) are encouraged to apply.ly.
Job Summary – Hetero Labs Ltd.
|
Company
|
Hetero Labs Ltd. |
|
Vacancies
|
Manager / Senior Manager – Regulatory Affairs (Formulations) |
|
Required Education
|
B.Pharm, M.Pharm, Pharm.D, M.Sc. Pharmaceutical Chemistry or M.Sc. Chemistry (suggested relevant qualifications) |
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Experience
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10–15 Years |